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RxNews® - Clinical Updates

Features late-breaking developments in the fields of medicine and pharmacy, including landmark clinical trials and emerging evidence.

Imbruvica® (ibrutinib) – New Indication

January 19, 2017 – AbbVie announced the FDA approval of Imbruvica (ibrutinib) for the treatment of patients with marginal zone lymphoma (MZL) who require systemic therapy and have received at least one prior anti-CD20-based therapy.More.
Saphris® (asenapine) – Expanded Indication

January 13, 2017 – The FDA approved Allergan’s Saphris (asenapine) for maintenance monotherapy treatment of bipolar I disorder in adults.More.
Lucentis® (ranibizumab) – New Indication

January 5, 2017 – Genentech announced the FDA approval of Lucentis (ranibizumab) for the treatment of patients with myopic choroidal neovascularization (mCNV). More.
Synjardy®, Synjardy XR® (empagliflozin/metformin) – Label Update

December 23, 2016 – The FDA approved updates to Boehringer Ingelheim’s Synjardy (empagliflozin/metformin) and Synjardy XR (empagliflozin/metformin extended-release) drug labels about the risk reduction of cardiovascular (CV) death with Jardiance® (empagliflozin) use.More.
Adynovate® (antihemophilic factor [recombinant], PEGylated) – Expanded Indication

December 27, 2016 – Shire announced the FDA approval of Adynovate (antihemophilic factor [recombinant], PEGylated) injection, for use in children and adults with hemophilia A (congenital factor VIII deficiency) for on-demand treatment of bleeding and control of bleeding episodes, perioperative management, and routine prophylaxis to reduce the frequency of bleeding episodes.More.
Tresiba® (insulin degludec) – Expanded Indication

December 19, 2016 – Novo Nordisk announced the FDA approval of Tresiba (insulin degludec) to improve glycemic control in patients 1 year of age and older with diabetes mellitus.More.
Avastin® (bevacizumab) – Expanded Indication

December 6, 2016 – Genentech announced the FDA approval of Avastin (bevacizumab) injection, in combination with carboplatin and paclitaxel or in combination with carboplatin and gemcitabine, followed by Avastin as a single agent, for the treatment of patients with platinum-sensitive recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer. More.
Jardiance® (empagliflozin) – New Indication

December 2, 2016 – The FDA announced the approval of Eli Lilly and Boehringer Ingelheim’s Jardiance (empagliflozin) tablets, to reduce the risk of cardiovascular (CV) death in adult patients with type 2 diabetes mellitus (T2DM) and CV disease.More.
Kaletra® (lopinavir/ritonavir) – Updated Contraindications/Drug Interactions

November 22, 2016 – The FDA approved new updates to the Contraindications and Drug Interactions sections of the drug label for Kaletra (lopinavir/ritonavir) pertaining to the addition of new drugs.More.
Renvela® (sevelamer) – Expanded Indication

November 25, 2016 – The FDA approved Genzyme’s Renvela (sevelamer) tablets and oral suspension, for the control of serum phosphorus in adults and children 6 years of age and older with chronic kidney disease (CKD) on dialysis.More.
Veltassa® (patiromer) – Removal of Boxed Warning

November 28, 2016 – Galenica announced updates to the drug label for Veltassa (patiromer) including removal of the boxed warning.More.
Cefzil® (cefprozil), Ceftin® (cefuroxime) – Indication Removal

November 22, 2016 – The FDA announced the removal of the indication for secondary bacterial infection of acute bronchitis (SBIAB) from the Cefzil (cefprozil) and Ceftin (cefuroxime axetil) drug labels.More.
FluLaval® Quadrivalent (influenza vaccine) – Expanded Indication

November 18, 2016 – GlaxoSmithKline announced the FDA approval of FluLaval Quadrivalent (influenza vaccine) for active immunization for the prevention of disease caused by influenza A subtype viruses and type B viruses contained in the vaccine. FluLaval Quadrivalent is approved for use in persons ≥ 6 months of age. More.
Naftin® (naftifine) 2% cream – Expanded Indication

November 10, 2016 – The FDA approved Merz’s Naftin (naftifine) 2% cream, to include additional data in pediatric subjects aged 2 years to 17 years 11 months with tinea corporis.More.
U.S. Preventive Services Task Force – Guideline Update on Statin Use for the Primary Prevention of Cardiovascular Disease in Adults: Preventive Medication

November 13, 2016 – The U.S. Preventive Services Task Force (USPSTF) released the 2016 Final Recommendation Statement on Statin Use for the Primary Prevention of Cardiovascular Disease in Adults: Preventive Medication. More.
Opdivo™ (nivolumab) – New Indication

November 8, 2016 – The FDA approved Opdivo (nivolumab) for the treatment of patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) with disease progression on or after platinum-based therapy.More.
Enbrel® (etanercept) – Expanded Indication

November 4, 2016 – Amgen announced the FDA approval of Enbrel (etanercept) for the treatment of patients 4 years or older with chronic moderate to severe plaque psoriasis (PsO) who are candidates for systemic therapy or phototherapy. More.
Selzentry® (maraviroc) – Expanded Indication, New Formulation

November 4, 2016 – The FDA announced Viiv Healthcare’s Selzentry (maraviroc) 20 mg/mL oral solution and 25 mg and 75 mg tablets in combination with other antiretroviral agents for the treatment of only CCR5-tropic human immunodeficiency virus type 1 (HIV-1) infection in patients 2 years of age and older weighing at least 10 kg.More.
Keytruda® (pembrolizumab) – New and Updated Indications

October 24, 2016 – The FDA announced the approval of Merck’s Keytruda (pembrolizumab) for the first line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have high PD-L1 expression [(tumor proportion score (TPS) ≥ 50%)] as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations.More.
Tarceva® (erlotinib) – Updated Indication

October 18, 2016 – The FDA approved Tarceva (erlotinib) for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations as detected by an FDA-approved test receiving first-line, maintenance, or second or greater line treatment after progression following at least one prior chemotherapy regimen.More.
Zemplar® (paricalcitol) – Expanded Indications

October 18, 2016 – The FDA announced the approval of AbbVie’s Zemplar (paricalcitol) capsules for pediatric patients 10 years and older for the prevention and treatment of secondary hyperparathyroidism associated with chronic kidney disease (CKD) stages 3 and 4 and CKD stage 5 in patients on hemodialysis or peritoneal dialysisMore.
Tecentriq® (atezolizumab) – New Indication

October 18, 2016 – Genentech announced the FDA approval of Tecentriq (atezolizumab) for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) who have disease progression during or following platinum-containing chemotherapy.More.
Orkambi® (lumacaftor/ivacaftor) – Expanded Indication and New Dosage Form

September 28, 2016 – Vertex announced the FDA approval of Orkambi (lumacaftor/ivacaftor), for the treatment of cystic fibrosis (CF) in patients age 6 years and older who are homozygous for the F508del mutation in the CFTR gene.More.
Stelara™ (ustekinumab) – New Indication

September 26, 2016 – Janssen announced the FDA approval of Stelara (ustekinumab) for the treatment of adult patients with moderately to severely active Crohn’s disease (CD) who have failed or were intolerant to treatment with immunomodulators or corticosteroids, but never failed treatment with a tumor necrosis factor (TNF) blocker; or failed or were intolerant to treatment with one or more TNF blockers.More.
Ilaris® (canakinumab) – New Indications

September 23, 2016 – The FDA announced the approval of Novartis’ Ilaris (canakinumab) for the following indications in adult and pediatric patients:More.
Arzerra® (ofatumumab) – Expanded Indication

August 31, 2016 – Genmab announced the FDA approval of Arzerra (ofatumumab) in combination with fludarabine and cyclophosphamide (FC) for the treatment of patients with relapsed chronic lymphocytic leukemia (CLL).More.
Trokendi XR® (topiramate) – Expanded Indication

August 18, 2016 – The FDA approved Supernus Pharmaceuticals’ Trokendi XR (topiramate) extended-release capsules in patients ≥ 6 years of age as initial monotherapy for partial onset or primary generalized tonic-clonic seizures. Safety and effectiveness in patients who were converted to monotherapy from a previous regimen of other anticonvulsant drugs have not been established in controlled trials.More.
Keytruda® (pembrolizumab) – New Indication

August 8, 2016 – Merck announced the FDA approval of Keytruda (pembrolizumab) for the treatment of patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) with disease progression on or after platinum-containing chemotherapy.More.
Dysport® (abobotulinumtoxinA) – New Indication

August 1, 2016 – Ispen Biopharmaceuticals announced the FDA approval of Dysport (abobotulinumtoxinA) for injection for the treatment of lower limb spasticity in pediatric patients two years of age and older.More.
Namzaric® (memantine/donepezil) – Expanded Indication

July 19, 2016 – Allergan and Adamas announced the FDA approval of Namzaric (memantine/ donepezil hydrochlorides) extended-release (ER) capsules, for the treatment of moderate to severe dementia of the Alzheimer’s type in patients stabilized on 10 mg of donepezil hydrochloride once daily.More.
Photrexa® Viscous (riboflavin 5’-phosphate in 20% dextran) and Photrexa® (riboflavin 5’-phosphate) – New Indication

July 19, 2016 – Avedro announced the FDA approval of Photrexa Viscous (riboflavin 5’-phosphate in 20% dextran) and Photrexa (riboflavin 5’-phosphate) for ophthalmic use with the KXL® System in corneal collagen cross-linking (CXL) for the treatment of corneal ectasia following refractive surgery.More.
Synjardy® (empagliflozin/metformin) – Expanded Indication

July 19, 2016 – Boehringer Ingelheim announced the FDA approval of Synjardy (empagliflozin/ metformin) tablets, as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus (T2DM) when treatment with both empagliflozin and metformin is appropriate.More.
Berinert® (C1 esterase inhibitor [human]) – Expanded Indication

July 18, 2016 – CSL Behring announced the FDA approval of Berinert (C1 esterase inhibitor [human]) injection, for the treatment of acute abdominal, facial, or laryngeal hereditary angioedema (HAE) attacks in adult and pediatric patients.More.
Prezista® (darunavir) – Expanded Indication

July 18, 2016 – Janssen Therapeutics announced the FDA approval of an expansion to the prescribing information for Prezista (darunavir) to include dosing recommendations for pregnant women with human immunodeficiency virus (HIV-1) and results from a study investigating the use of Prezista during pregnancy and the postpartum period.More.
Biosimilar Humira® (adalimumab) and Enbrel® (etanercept) – FDA Advisory Committee Recommendations

July 12-13, 2016 – The FDA held Advisory Committee Meetings to discuss Amgen’s ABP 501, a proposed biosimilar to AbbVie's Humira (adalimumab) and Sandoz’s GP2015, a proposed biosimilar to Amgen’s Enbrel (etanercept).More.
Prevnar™ 13 (pneumococcal 13-valent conjugate vaccine [diphtheria CRM197 protein]) – Expanded Indication

July 12, 2016 – Pfizer announced the FDA approval of Prevnar 13 (pneumococcal 13-valent conjugate vaccine [diphtheria CRM197 protein]) for active immunization for the prevention of pneumonia and invasive disease caused by S. pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F in adults 18 years of age and older.More.
Dexlansoprazole [Dexilant™, Dexilant™ SoluTab] – Expanded Indication

July 11, 2016 – Takeda announced the FDA approval of dexlansoprazole (Dexilant delayed-release capsules, Dexilant SoluTab orally disintegrating tablets) for the expansion of the current indications to include pediatric patients 12 to 17 years of age.More.
Kepivance® (palifermin) – Label Update

July 1, 2016 – The FDA approved a safety update for Kepivance (palifermin) pertaining to the risk of exacerbated mucositis in patients with hematologic malignancies receiving myelotoxic therapy in the setting of allogeneic hematopoietic stem cell support.More.
Xolair® (omalizumab) – Expanded Indication

July 6, 2016 – The FDA approved Genentech’s Xolair (omalizumab) for use in patients 6 years of age and older with moderate to severe asthma who have a positive skin test or in vitro reactivity to a perennial aeroallergen and whose symptoms are inadequately controlled with inhaled corticosteroids.More.
Humira® (adalimumab) – New Orphan Indication

June 30, 2016 – AbbVie announced the FDA approval of Humira (adalimumab), for the treatment of non-infectious intermediate, posterior and panuveitis in adult patients.More.
LEADER Trial – Results from a Diabetes Trial

June 13, 2016 – The Liraglutide Effect and Action in Diabetes: Evaluation of Cardiovascular Outcome Results—A Long Term Evaluation (LEADER) study was published in the New England Journal of Medicine. Novo Nordisk’s Victoza® (liraglutide) significantly reduced the rates of major adverse cardiovascular events (MACE) and death in type 2 diabetes mellitus (T2DM) patients at elevated cardiovascular risk.More.
Tivicay® (dolutegravir) – Expanded Indication

June 10, 2016 – ViiV Healthcare announced the FDA approval of Tivicay (dolutegravir) in combination with other antiretroviral agents for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults and pediatric patients weighing at least 30 kg. More.
Teflaro® (ceftaroline) – Expanded Indication

May 31, 2016 – Allergan announced the FDA approval of Teflaro (ceftaroline), indicated for adult and pediatric patients 2 months of age and older for the treatment of the following infections caused by susceptible bacteria: acute bacterial skin and skin structure infections (ABSSSI) and community-acquired bacterial pneumonia (CABP).More.
Crestor® (rosuvastatin) – Expanded Indication

May 27, 2016 – The FDA approved AstraZeneca’s Crestor (rosuvastatin) tablets, as an adjunct to diet to reduce low density lipoprotein-cholesterol (LDL-C), total cholesterol (Total-C), non-high density lipoprotein-cholesterol (non-HDL-C), and apolipoprotein B (Apo-B) in children and adolescents 7 – 17 years of age with homozygous familial hypercholesterolemia (HoFH), either alone or with other lipid-lowering treatments (eg, LDL apheresis).More.
American College of Cardiology, American Heart Association, and the Heart Failure Society of America – Focused Update on New Pharmacological Therapy for Heart Failure

May 20, 2016 – An Update of the 2013 ACCF/AHA Guideline for the Management of Heart Failure: The updated guideline includes Entresto™ (valsartan/sacubitril) and Corlanor® (ivabradine) as treatment options in select patients with heart failure.More.
Invokamet® (canagliflozin/metformin) – Expanded Indication

May 20, 2016 – The FDA approved Janssen’s Invokamet (canagliflozin/metformin) as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus (T2DM) when treatment with both canagliflozin and metformin is appropriate. This expands Invokamet’s use as initial treatment in T2DM. More.
Olysio® (simeprevir) – Updated Indication

May 20, 2016 – The FDA approved Janssen’s Olysio (simeprevir) for the treatment of adults with chronic hepatitis C virus (HCV) infection: in combination with Sovaldi® (sofosbuvir) in patients with HCV genotype 1 without cirrhosis or with compensated cirrhosis; and in combination with peginterferon alfa (Peg-IFN-alfa; Pegasys® or Peg-Intron®) and ribavirin (RBV) in patients with HCV genotype 1 or 4 without cirrhosis or with compensated cirrhosis.More.
Opdivo® (nivolumab) – New Orphan Indication

May 17, 2016 – The FDA announced the approval of Bristol-Myer’s Squibb’s Opdivo (nivolumab) for classical Hodgkin lymphoma (cHL) that has relapsed or progressed after autologous hematopoietic stem cell transplantation (HSCT) and post-transplantation Adcetris® (brentuximab vedotin).More.
Lenvima® (lenvatinib) – New Indication

May 13, 2016 – Eisai announced the FDA approval of Lenvima (lenvatinib), in combination with Afinitor® (everolimus), for patients with advanced renal cell cancer (RCC) following one prior anti-angiogenic therapy. More.
Imbruvica® (ibrutinib) – New Indication

May 9, 2016 – AbbVie announced the FDA approval of Imbruvica (ibrutinib) for the treatment of patients with small lymphocytic lymphoma (SLL) with or without the deletion of chromosome 17p (del17p). More.
Entocort® EC (budesonide) – Expanded Indication

May 4, 2016 – The FDA approved Elan’s Entocort EC (budesonide), for the treatment of mild to moderate active Crohn’s disease involving the ileum and/or ascending colon in patients 8 years of age and older.More.
Brintellix® (vortioxetine) – Brand Name Change to Trintellix

May 2, 2016 – The FDA and Takeda announced that the antidepressant Brintellix (vortioxetine) will be marketed under the new name, Trintellix. The name change is to decrease the risk of prescribing and dispensing errors resulting from name confusion with the blood-thinning medicine Brilinta® (ticagrelor).More.
ProAir RespiClick® (albuterol sulfate) – Expanded Indication

April 29, 2016 – Teva Pharmaceuticals announced the FDA approval of ProAir RespiClick (albuterol sulfate), for the treatment or prevention of bronchospasm in patients 4 years of age and older with reversible obstructive airway disease, and for the prevention of exercise-induced bronchospasm in patients 4 years of age and older.More.
Viekira Pak® (ombitasvir/paritaprevir/ritonavir; dasabuvir) – Expanded Indication

April 25, 2016 –¬ AbbVie announced the FDA approval of Viekira Pak (ombitasvir/paritaprevir/ritonavir; dasabuvir) for the treatment of adult patients with chronic hepatitis C virus (HCV) genotype 1b without cirrhosis or with compensated cirrhosis.More.
Niacin Extended-Release and Fenofibric Acid Delayed-Release Products – Withdrawal of Approval

April 18, 2016 – The FDA announced that it is withdrawing approval of the indications related to the co-administration with a statin for niacin-extended release (ER) tablets (Niaspan®) and fenofibric acid delayed-release (DR) capsules (Trilipix®).More.
Gilotrif® (afatinib) – Expanded Indication

April 15, 2015 – Boehringer Ingelheim announced the FDA approval of Gilotrif (afatinib) tablets, for the treatment of patients with metastatic squamous non-small cell lung cancer (NSCLC) progressing after platinum-based chemotherapy.More.
Luveris® (lutropin alfa) – Withdrawal of Drug Application

On April 12, 2016, the FDA announced the withdrawal of the new drug application (NDA) held by EMD Serono for Luveris (lutropin alfa) injection due to the manufacturer’s failure to complete clinical studies required as a condition of approval and to verify the product’s efficacy.More.
Mifeprex® (mifepristone) – Label Updates

March 30, 2016 – Danco Laboratories announced the FDA approval of Mifeprex (mifepristone), indicated, in a regimen with Cytotec® (misoprostol), for the medical termination of intrauterine pregnancy through 70 days gestation.More.
Prescribing Opioids for Chronic Pain – Treatment Guidelines

March 15, 2016 – The Centers for Disease Control and Prevention (CDC) announced the release of guidelines for prescribing opioids for chronic pain.More.
Xalkori® (crizotinib) – New Orphan Indication

March 11, 2016 – Pfizer announced the FDA approval of Xalkori (crizotinib) for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are ROS1-positive.More.
Truvada® (emtricitabine/tenofovir disoproxil fumarate) – Expanded Indication

March 10, 2016 – The FDA approved Truvada (emtricitabine/tenofovir disoproxil fumarate) for the treatment of human immunodeficiency virus-1 (HIV-1) infection in pediatric patients weighing ≥ 17 kg.More.
Imbruvica® (ibrutinib) – Expanded Indication

March 4, 2016 – AbbVie announced the FDA approval of Imbruvica (ibrutinib) for the treatment of patients with chronic lymphocytic leukemia (CLL).More.
Faslodex® (fulvestrant) – Expanded Indication

March 2, 2016 – AstraZeneca announced the FDA approval of Faslodex (fulvestrant), for the treatment of hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) advanced or metastatic breast cancer in combination with Ibrance® (palbociclib) in women with disease progression after endocrine therapy.More.
Afinitor® (everolimus) – New Indication, Label Updates

February 26, 2016 – Novartis announced the FDA approval of Afinitor (everolimus), for the treatment of adults with progressive, well-differentiated, non-functional neuroendocrine tumors (NET) of gastrointestinal or lung origin with unresectable, locally advanced or metastatic disease.More.
Gazyva® (obinutuzumab) – New Indication

February 26, 2016 – Genentech announced the FDA approval of Gazyva (obinutuzumab) in combination with bendamustine (eg, Bendeka™, Treanda®) followed by Gazyva monotherapy, for the treatment of patients with follicular lymphoma (FL) who relapsed after, or are refractory to, a rituximab-containing regimen.More.
Complera® (emtricitabine/rilpivirine/tenofovir disoproxil fumarate) – Expanded Indication

February 23, 2016 – The FDA approved Gilead Sciences’ Complera (emtricitabine/rilpivirine/ tenofovir disoproxil fumarate), for use as a complete regimen for the treatment of HIV-1 infection in patients 12 years of age and older with no antiretroviral treatment history and with HIV-1 RNA < 100,000 copies/mL at the start of therapy.More.
Ibrance® (palbociclib) – Expanded Indication

February 19, 2016 – Pfizer announced the FDA approval of Ibrance (palbociclib), for the treatment of hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) advanced or metastatic breast cancer in combination with Faslodex® (fulvestrant) in women with disease progression following endocrine therapy.More.
Harvoni® (ledipasvir/sofosbuvir) – Expanded Indications

February 12, 2016 – The FDA approved Gilead’s Harvoni (ledipasvir/sofosbuvir), to include patients with chronic hepatitis C virus (HCV) genotype 1 or genotype 4 infection who are liver transplant recipients without cirrhosis or with compensated cirrhosis, and patients with HCV genotype 1 infection with decompensated cirrhosis.More.
Daklinza™ (daclatasvir) – New Indication

February 5, 2016 – Bristol-Myers Squibb announced the FDA approval of Daklinza (daclatasvir) for use with Sovaldi® (sofosbuvir), with or without ribavirin, for the treatment of patients with chronic hepatitis C virus (HCV) genotype 1 or genotype 3 infection.More.
Prilosec® (omeprazole) Oral Suspension – Expanded Indication

February 3, 2016 – The FDA announced the approval of AstraZeneca’s Prilosec (omeprazole) oral suspension, for the short-term treatment (up to 6 weeks) of erosive esophagitis (EE) due to acid-mediated gastroesophageal reflux disease (GERD) in pediatric patients 1 month to less than 1 year of age.More.
Halaven® (eribulin mesylate) – New Orphan Indication

January 28, 2016 – The FDA announced the approval of Eisai’s Halaven (eribulin mesylate) for the treatment of patients with unresectable or metastatic liposarcoma who have received a prior anthracycline-containing regimen.More.
Opdivo® (nivolumab) – Expanded Indications

January 23, 2016 – Bristol-Myers Squibb announced the FDA approval of Opdivo (nivolumab) for two expanded indications: (1) as a single agent for the treatment of patients with BRAF V600 mutation-positive unresectable or metastatic melanoma; (2) in combination with Yervoy® (ipilimumab) for the treatment of patients with unresectable or metastatic melanoma.More.
Botox® (onabotulinumtoxinA) – Expanded Indication

January 22, 2016 – Allergan announced the FDA approval of Botox (onabotulinumtoxinA) injection, for the treatment of lower limb spasticity in adult patients to decrease the severity of increased muscle tone in ankle and toe flexors (gastrocnemius, soleus, tibialis posterior, flexor hallucis longus, and flexor digitorum longus).More.
Kyprolis® (carfilzomib) – Expanded Indications

January 21, 2015 – Amgen announced the FDA approval of Kyprolis (carfilzomib) injection, for the following two indications: (1) in combination with dexamethasone or with lenalidomide plus dexamethasone for the treatment of patients with relapsed or refractory multiple myeloma (MM) who have received 1 to 3 lines of therapy; (2) as a single agent for the treatment of patients with relapsed or refractory MM who have received 1 or more lines of therapy. More.
Flebogamma® 10% DIF (immune globulin intravenous [human]) – New Indication

January 21, 2016 – The FDA announced the approval of Instituto Grifols’ Flebogamma 10% DIF (immune globulin intravenous [human]), for the treatment of chronic primary immune thrombocytopenia (ITP) in patients 2 years of age and older. More.
Arzerra® (ofatumumab) – Expanded Indication

January 19, 2016 – The FDA announced the approval of Novartis’ Arzerra (ofatumumab), for extended treatment of patients who are in complete or partial response after ≥ 2 lines of therapy for recurrent or progressive chronic lymphocytic leukemia (CLL). More.
Cosentyx® (secukinumab) – New Indications

January 15, 2016 – Novartis announced the FDA approval of Cosentyx (secukinumab) for the treatment of two new indications, adult patients with active psoriatic arthritis (PsA) and active ankylosing spondylitis (AS).More.
Hiberix® (Haemophilus b conjugate [tetanus toxoid conjugate]) – Expanded Indication

January 14, 2016 – The FDA approved GlaxoSmithKline’s Hiberix (Haemophilus b conjugate [tetanus toxoid conjugate]) vaccine for active immunization for the prevention of invasive disease cause by Haemophilus influenza type b (Hib) in children 6 weeks through 4 years of age (prior to fifth birthday).More.
Xeomin® (incobotulinumtoxinA) – New Indication

December 23, 2015 – Merz North America announced the FDA approval of Xeomin (incobotulinumtoxinA) injection, for the treatment of upper limb spasticity (ULS) in adult patients. More.
Keytruda® (pembrolizumab) – Expanded Indication

December 18, 2015 – Merck announced the FDA approval of Keytruda (pembrolizumab) for the treatment of patients with unresectable or metastatic melanoma. More.
Gardasil® 9 (HPV 9-valent vaccine, recombinant) – Expanded Indication

December 15, 2015 – Merck announced the FDA approval of Gardasil 9 (human papillomavirus [HPV] 9-valent vaccine, recombinant) for use in boys and men 16 – 26 years of age for the prevention of anal cancer cause by HPV types 16, 18, 31, 33, 45, 52, and 58; genital warts caused by HPV types 6 and 11; and anal intraepithelial neoplasia grades 1, 2, and 3 caused by HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58.More.
Zetia® and Vytorin® – FDA Advisory Meeting Recommendations

December 14, 2015 – The FDA’s Endocrinologic and Metabolic Drugs Advisory Committee met to discuss the results of the IMProved Reduction of Outcomes: Vytorin Efficacy International Trial (IMPROVE-IT) and the proposed indication for Merck’s Zetia (ezetimibe), in combination with a statin, and Vytorin (ezetimibe/simvastatin), to reduce the risk of cardiovascular (CV) events in patients with coronary heart disease (CHD).More.
Gamunex®-C (immune globulin injection [human]) – Expanded Indication

December 4, 2015 – The FDA approved Grifols Therapeutics’ Gamunex® -C (immune globulin injection [human], 10% caprylate/chromatography purified), for subcutaneous (SC) administration in the treatment of primary humoral immunodeficiency (PI) in patients 2 years of age and older.More.
Crestor® (rosuvastatin) – Expanded Indication

November 24, 2015 – The FDA approved AstraZeneca’s Crestor (rosuvastatin), indicated for pediatric patients 8 – 17 years of age with heterozygous familial hypercholesterolemia (HeFH) to reduce elevated total cholesterol, low-density lipoprotein cholesterol (LDL-C) and apolipoprotein B after failing an adequate trial of diet therapy.More.
Caldolor® (ibuprofen) – Expanded Indication

November 23, 2015 – Cumberland Pharmaceuticals announced the FDA approval of Caldolor (ibuprofen) for pediatric patients ≥ 6 months of age for the management of mild to moderate pain, management of moderate to severe pain as an adjunct to opioid analgesics, and reduction of fever.More.
Opdivo® (nivolumab) – New and Expanded Indications

November 23, 2015 – The FDA announced the approval of Bristol-Myers Squibb’s Opdivo (nivolumab) for the treatment of advanced renal cell carcinoma (RCC) in patients who have received prior anti-angiogenic therapy. In addition, on November 24, 2015, Bristol-Myers Squibb announced the FDA approval of Opdivo as a single agent, for the treatment of patients with BRAF V600 wild-type unresectable or metastatic melanoma (MM).More.
Pradaxa® (dabigatran) – New Indication

November 23, 2015 – Boehringer Ingelheim announced the FDA-approval of Pradaxa (dabigatran), for the prophylaxis of deep vein thrombosis (DVT) and pulmonary embolism (PE) in patients who have undergone hip replacement surgery.More.
Methotrexate (preservative) injection – Label Update

November 20, 2015 – The FDA approved changes to the Indications and Boxed Warnings sections of Hospira’s methotrexate (preservative) injection label to revise the indication for acute lymphocytic leukemia (ALL) and the boxed warning regarding formulation selection.More.
Neulasta® (pegfilgrastim) – New Indication

November 13, 2015 – The FDA approved Amgen’s Neulasta (pegfilgrastim) injection, to increase survival in patients acutely exposed to myelosuppressive doses of radiation (Hematopoietic Subsyndrome of Acute Radiation Syndrome).More.
Harvoni® (ledipasvir/sofosbuvir) – Expanded Indications

November 12, 2015, Gilead Sciences announced the FDA approval of Harvoni (ledipasvir/sofosbuvir), for expanded use in patients with genotype (GT) 4, 5 and 6 chronic hepatitis C virus (HCV) infection, in patients co-infected with human immunodeficiency virus (HIV), and in treatment-experienced, GT1 patients with cirrhosis for 12 weeks in combination with ribavirin.More.
Antihypertensive Therapy – Results from the SPRINT Trial

November 9, 2015 – The SPRINT trial was recently published in the New England Journal of Medicine. Lowering systolic blood pressure (SBP) to < 120 mm Hg in patients at high risk for cardiovascular (CV) events but without diabetes significantly decreased the rates of fatal and nonfatal CV events and death from any cause.More.
Fluoroquinolones – FDA Advisory Meeting Recommendations

November 5, 2015 – The FDA held a joint meeting of the Antimicrobial Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee to discuss the risks and benefits of the systemic fluoroquinolones for the treatment of acute bacterial sinusitis (ABS), acute bacterial exacerbation of chronic bronchitis in patients who have chronic obstructive pulmonary disease (ABECB-COPD), and uncomplicated urinary tract infections (UTI).More.
Yervoy® (ipilimumab) – New Indication

October 28, 2015 – The FDA announced the approval of Bristol-Myers Squibb’s Yervoy (ipilimumab), for the adjuvant treatment of patients with cutaneous melanoma with pathologic involvement of regional lymph nodes of more than 1 mm who have undergone complete resection, including total lymphadenectomy.More.
Opdivo® (nivolumab) – Expanded Indication

October 9, 2015 – The FDA announced the approval of Bristol-Myers Squibb’s Opdivo (nivolumab), for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy.More.
Olysio® (simeprevir) – Expanded Indication

October 5, 2015 – The FDA approved the use of Janssen’s Olysio (simeprevir), for the treatment of chronic hepatitis C (CHC) genotype 1 or 4 infection as a component of a combination antiviral treatment regimen.More.
Keytruda® (pembrolizumab) – New Indication

October 2, 2015 – The FDA announced the approval of Merck’s Keytruda (pembrolizumab) for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors express PD-L1 as determined by an FDA-approved test with disease progression on or after platinum-containing chemotherapy.More.
Letairis® (ambrisentan) – New Indication

October 2, 2015 – Gilead announced the FDA approval of Letairis (ambrisentan), an endothelin receptor antagonist, for the treatment of pulmonary arterial hypertension (PAH) (World Health Organization [WHO] Group 1) in combination with tadalafil to reduce the risks of disease progression and hospitalization for worsening PAH, and to improve exercise ability.More.
Opdivo® (nivolumab) – New Indication

October 1, 2015 – Bristol-Myers Squibb announced the FDA approval of Opdivo (nivolumab), in combination with Yervoy® (ipilimumab) for the treatment of patients with BRAF V600 wild-type, unresectable or metastatic melanoma.More.
Reyataz® (atazanavir) – Expanded Indication

September 24, 2015 – The FDA approved Bristol-Myers Squibb’s Reyataz (atazanavir) oral powder, a protease inhibitor, for use in combination with other antiretroviral agents for the treatment of human immunodeficiency virus type 1 (HIV-1) infection for patients ≥ 3 months of age weighing at least 5 kg.More.
Jardiance® (empagliflozin) – Cardiovascular Outcomes Trial Results

September 17, 2015 – Eli Lilly and Boehringer Ingelheim announced that Jardiance (empagliflozin) demonstrated significant reductions in cardiovascular (CV) risk and CV death in a dedicated outcome trial.More.
Spiriva® Respimat® (tiotropium) — New Indication

September 16, 2015 — Boehringer Ingelheim announced the FDA approval of Spiriva Respimat (tiotropium), an anticholinergic, for the long-term, once-daily, maintenance treatment of asthma in patients 12 years of age and older.More.
Humira® (adalimumab) — New Orphan Indication

September 10, 2015 — AbbVie announced the FDA approval of Humira (adalimumab), for the treatment of moderate to severe hidradenitis suppurativa (HS).More.
Delzicol® (mesalamine) – Expanded Indication

September 9, 2015 – The FDA approved Actavis’ Delzicol (mesalamine) delayed-release capsules, for the treatment of mildly to moderately active ulcerative colitis (UC) in patients ≥ 5 years of age.More.
Brilinta® (ticagrelor) — Expanded Indication and New Strength

September 3, 2015 — AstraZeneca announced the FDA approval of Brilinta (ticagrelor), a P2Y12 platelet inhibitor, at a new 60 mg dose, to be used in patients with a history of heart attack beyond the first year. With this expanded indication, Brilinta is now approved to reduce the rate of cardiovascular (CV) death, myocardial infarction (MI), and stroke in patients with acute coronary syndrome (ACS) or a history of MI.More.
Emend® (aprepitant) — Expanded Indication

September 2, 2015 — Merck announced the FDA approval of Emend (aprepitant), in combination with other antiemetic agents in patients ≥ 12 years of age and patients ˂ 12 years of age who weigh at least 30 kg, for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy (HEC) including high-dose cisplatin, and nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC). More.
Edurant® (rilpivirine) — Expanded Indication

August 26, 2015 — The FDA approved Janssen’s Edurant (rilpivirine), in combination with other antiretroviral agents, for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in antiretroviral treatment-naïve patients with HIV-1 RNA ≤ 100,000 copies/mL at the start of therapy.More.
Aptiom® (eslicarbazepine) — Expanded Indication

August 28, 2015 — Sunovion announced the FDA approval of Aptiom (eslicarbazepine) for the treatment of partial-onset seizures as monotherapy.More..
Promacta® (eltrombopag) — New Formulation with Expanded Indication

August 24, 2015 — Novartis announced the FDA approval of Promacta (eltrombopag) for the treatment of thrombocytopenia in adult and pediatric patients ≥ 1 year of age with chronic immune (idiopathic) thrombocytopenia (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy.More..
Adcetris® (brentuximab) — New Indication

August 17, 2015 — Seattle Genetics announced the FDA approval of Adcetris (brentuximab vedotin) injection, for the treatment of patients with classical Hodgkin lymphoma (HL) at high risk of relapse or progression as post-autologous hematopoietic stem cell transplantation (auto-HSCT) consolidation.More..
Procysbi® (cysteamine) — Expanded Indication

August 17, 2015 — Raptor Pharmaceuticals announced the FDA approval of Procysbi (cysteamine bitartrate) for the treatment of nephropathic cystinosis in adult and pediatric patients 2 years of age and older.More..
OxyContin® (oxycodone) – Expanded Indication

August 13, 2015 — The FDA approved Purdue Pharma’s OxyContin (oxycodone) for pain.More..
Gammaplex® (immune globulin intravenous [human], 5% liquid) — Expanded Indication

August 6, 2015 — Bio Products Laboratory announced the FDA approval of Gammaplex (immune globulin intravenous [human], 5% liquid) for the treatment of primary humoral immunodeficiency (PI) in adults and pediatric patients 2 years of age and older. More..
Zubsolv® (buprenorphine/naloxone) — Expanded Indication

August 11, 2015 — Orexo announced the FDA approval of Zubsolv (buprenorphine/naloxone) for the treatment of opioid dependence and should be used as part of a complete treatment plan to include counseling and psychosocial support. More..
Wilate® (von Willebrand factor/coagulation factor VIII complex [human]) — New Indication

August 13, 2015 — Octapharma USA announced the FDA approval of Wilate (von Willebrand factor/coagulation factor VIII complex [human]), in children and adults with von Willebrand disease (VWD) for on-demand treatment and control of bleeding episodes, and for perioperative management of bleeding. More..
Kyprolis® (carfilzomib) — Expanded Indication

July 24, 2015 — The FDA announced the approval of Amgen’s Kyprolis (carfilzomib) in combination with Revlimid® (lenalidomide) and dexamethasone for the treatment of patients with relapsed multiple myeloma (MM) who have received one to three prior lines of therapy.More..
Dysport® (abobotulinumtoxinA) — New Indication

July 16, 2015 — Ispen announced the FDA approval of Dysport (abobotulinumtoxinA) for the treatment of upper limb spasticity in adult patients, to decrease the severity of increased muscle tone in the elbow, wrist, and finger flexors. More..
Iressa® (gefitinib) — Expanded Indication

July 13, 2015 — The FDA announced the approval of AstraZeneca’s Iressa (gefitinib) tablets, for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations as detected by an FDA-approved test.More..
Fycompa® (perampanel) — New Indication

June 22, 2015 — Eisai announced the FDA approval of Fycompa (perampanel) as adjunctive therapy for the treatment of primary generalized tonic-clonic seizures in patients with epilepsy 12 years of age and older.More..
Zomig® (zolmitriptan) Nasal Spray — Expanded Pediatric Indication

June, 12, 2015 — The FDA announced the approval of Impax Laboratories’ Zomig (zolmitriptan) nasal spray for the acute treatment of migraine with or without aura in adults and pediatric patients 12 years of age and older.More..
Promacta® (eltrombopag) — Expanded Pediatric Indication

June 11, 2015 — The FDA approved Novartis’ Promacta (eltrombopag) for the treatment of thrombocytopenia in adult and pediatric patients 6 years and older with chronic immune (idiopathic) thrombocytopenia (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy.More..
Rapamune® (sirolimus) — New Orphan Indication

May 29, 2015 — Pfizer announced the FDA approval of Rapamune (sirolimus) for the treatment of patients with lymphangioleiomyomatosis (LAM).More..
Prezista® (darunavir) — Drug Label Updates

May 27, 2015 — The FDA approved updates to the Contraindications and Drug-Drug Interactions sections of the Prezista (darunavir) drug label.More..
Xifaxan® (rifaximin) — New Indication

May 27, 2014 — Salix announced the FDA approval of Xifaxan (rifaximin) for the treatment of IBS-D in adults.More..
Avelox® (moxifloxacin) — New Indication

May 8, 2015 — The FDA announced the approval of Avelox (moxifloxacin) for the treatment and prophylaxis of plague due to Yersinia pestis in adult patients.More..
Breo® Ellipta® — Updated Indication, Safety Updates

April 30, 2015 — GlaxoSmithKline and Theravance announced the FDA approval of Breo Ellipta (fluticasone furoate/vilanterol) for the once-daily treatment of asthma in patients ≥ 18 years of age.More..
Niaspan® (niacin extended-release) — Indication Removal

April 27, 2015 — The FDA approved revisions for AbbVie’s Niaspan (niacin extended-release) tablets to remove the following indication from its package insert and related labeling statements regarding the combined use of Niaspan and statins.More..
Trilipix™ (fenofibric acid) — Indication Removal

April 27, 2015 — The FDA issued a letter approving the removal of an indication for AbbVie’s Trilipix (fenofibric acid). More..
Cyramza® (ramucirumab) — New Indication

April 24, 2015 — Eli Lilly announced the FDA approval of Cyramza (ramucirumab) injection, in combination with FOLFIRI (irinotecan, folinic acid [ie, leucovorin], and 5-fluorouracil), for the treatment of patients with metastatic colorectal cancer (mCRC) with disease progression on or after prior therapy with Avastin® (bevacizumab), Eloxatin® (oxaliplatin), and a fluoropyrimidine (eg, 5-fluorouracil).More..
Botox® (onabotulinumtoxin A) — Expanded Indication

April 20, 2015 — Actavis announced the FDA approval of Botox (onabotulinumtoxin A) for the treatment of upper limb spasticity in adult patients, to decrease the severity of increased muscle tone in elbow flexors (biceps), wrist flexors (flexor carpi radialis and flexor carpi ulnaris), finger flexors (flexor digitorum profundus and flexor digitorum sublimis), and thumb flexors (adductor pollicis and flexor pollicis longus).More..
Onglyza®, Kombiglyze® XR, Nesina®, Oseni®, and Kazano® — FDA Advisory Committee Recommendations

April 14, 2015 — The FDA held an Advisory Committee Meeting to discuss the results of two cardiovascular outcomes trials (CVOTs) regarding Onglyza (saxagliptin), Kombiglyze XR (saxagliptin/metformin), Nesina (alogliptin), Oseni (alogliptin/pioglitazone), and Kazano (alogliptin/metformin): (1) Saxagliptin Assessment of Vascular Outcomes Recorded in Patients with Diabetes Mellitus (SAVOR), and (2) Examination of Cardiovascular Outcomes with Alogliptin versus Standard of Care (EXAMINE).More..
Neupogen® (filgrastim) — New Indication

March 30, 2015 — The FDA approved Amgen’s Neupogen (filgrastim) injection, to increase survival in patients acutely exposed to myelosuppressive doses of radiation (Hematopoietic Syndrome of Acute Radiation Syndrome).More..
Eylea® (aflibercept) — New Indication

March 25, 2015 — The FDA announced the approval of Regeneron’s Eylea (aflibercept) for the treatment of diabetic retinopathy (DR) in patients with diabetic macular edema (DME).More..
Cipro IV® (ciprofloxacin) — Label Update

March 19, 2015 — The FDA announced that the labeling for Bayer Healthcare’s Cipro IV (ciprofloxacin) will be revised to correct the text listed in the Indications and Usage section. More..
Kalydeco® (ivacaftor) — Expanded Population, New Formulation Approval

March 18, 2015 — Vertex announced the FDA approval of Kalydeco (ivacaftor) for the treatment of cystic fibrosis (CF) in patients age 2 years and older who have one the following mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene: G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N, S549R, or R117H. More..
Opdivo® (nivolumab) — New Indication

March 4, 2015 — The FDA announced the approval of Bristol-Myers Squibb’s Opdivo (nivolumab) for the treatment of patients with metastatic squamous non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy. More..
Astepro® (azelastine) — Expanded Indication

February 20, 2015 — The FDA approved Meda Pharmaceuticals’ Astepro (azelastine hydrochloride) 0.1% nasal spray for the relief of symptoms of seasonal allergic rhinitis in children 2 through 6 years of age and perennial allergic rhinitis in children 6 months through 6 years of age.More..
Dymista® (azelastine/fluticasone) — Expanded Indication

February 20, 2015 — Meda announced the FDA approval of Dymista (azelastine/fluticasone) for the relief of symptoms of seasonal allergic rhinitis in patients 6-11 years of age who require treatment with both components.More..
Revlimid® (lenalidomide) — Expanded Indication

February 18, 2015, Celgene announced the FDA approval of Revlimid (lenalidomide), for use in combination with dexamethasone for the treatment of patients with multiple myeloma.More..
Banzel® (rufinamide) — Expanded Indication

February 13, 2015 — Eisai announced the FDA approval of Banzel (rufinamide) tablets and oral suspension for adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome in pediatric patients 1 year of age and older, and in adults.More..
Lucentis® (ranibizumab) — New Indication

February 6, 2015 — The FDA approved Genentech’s Lucentis (ranibizumab injection) for the treatment of diabetic retinopathy [non proliferative diabetic retinopathy (NPDR), proliferative diabetic retinopathy (PDR)] in patients with diabetic macular edema (DME).More..
Cipro® (ciprofloxacin) — New Indication

February 2, 2015 — The FDA approved Cipro (ciprofloxacin) tablets, intravenous infusion and oral suspension for the treatment of plague, including pneumonic and septicemic plague, due to Yersinia pestis and prophylaxis for plague in adults and pediatric patients from birth to 17 years of age. More..
Vyvanse® (lisdexamfetamine dimesylate) — New Indication

January 30, 2015 — Shire announced the FDA approval of Vyvanse (lisdexamfetamine dimesylate) capsules, a Schedule II controlled substance, for moderate to severe binge eating disorder (BED). Vyvanse is the first FDA-approved medication for BED.More..
Imbruvica® (ibrutinib) — New Orphan Indication

January 29, 2015 — The FDA announced the approval of Janssen Biotech’s Imbruvica (ibrutinib) for the treatment of patients with Waldenström’s macroglobulinemia (WM).More..

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