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FDA Approves BMS’s Evotaz™ for the Treatment of HIV-1 Infection in Adults

January 30, 2015 8:42 am | News | Comments

Evotaz is coformulated to be one pill, once-daily, combining the protease inhibitor atazanavir, which is marketed as Reyataz (atazanavir 200 mg/300 mg) capsules, and cobicistat, a pharmacokinetic enhancer marketed by Gilead Sciences.   

FDA Approves IMBRUVICA for Treatment of Waldenstrom's Macroglobulinemia

January 29, 2015 12:54 pm | News | Comments

Pharmacyclics has announced that the FDA has granted single-agent IMBRUVICA (ibrutinib) regular...

FDA Approves Teva's Generic Nexium® Delayed-Release Capsules

January 27, 2015 7:06 am | News | Comments

Teva Pharmaceutical has announced the Food and Drug Administration (FDA) approval of the first...

CHMP Issues Positive Opinion for Merck's Investigational Antibiotic SIVEXTRO®

January 26, 2015 11:00 am | News | Comments

Merck announced that the Committee for Medicinal Products for Human Use of the European...

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FDA Approves Symplmed's Prestalia® for Treatment of Hypertension

January 26, 2015 10:44 am | News | Comments

Symplmed Pharmaceuticals has announced that the FDA has approved Prestalia® (perindopril arginine and amlodipine) tablets, licensed from Servier (Suresnes, France), for the treatment of hypertension.         

Impax Receives FDA Approval for a Generic Version of Lamictal

January 26, 2015 8:11 am | News | Comments

Impax Laboratories announced today that the  FDA has approved generic Lamictal (lamotrigine) Orally Disintegrating Tablets, 25mg, 50mg, 100mg and 200mg in blister packaging. Impax will promptly initiate commercialization of this product through Global Pharmaceuticals, Impax's generic division.

FDA Approves Baxter's PHOXILLUM Solution for Electrolyte Management During Continuous Renal Replacement Therapy

January 21, 2015 8:15 am | News | Comments

Baxter International has announced the FDA has approved PHOXILLUM Renal Replacement Solutions as replacement solutions in continuous renal replacement therapy to correct electrolyte and acid-base imbalances, and in case of drug poisoning when CRRT is used to remove dialyzable substances.

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Fresenius Kabi Receives FDA Approval for Neostigmine Methylsulfate Injection

January 19, 2015 9:33 am | News | Comments

This is the first Fresenius Kabi drug approved by the FDA since the agency upgraded the status of the company’s pharmaceutical manufacturing facility in Grand Island, N.Y., earlier this month.           

FDA Approves Appetite-Zapping Implant for Obese Patients

January 14, 2015 4:24 pm | News | Comments

The Maestro Rechargeable System uses electrodes implanted in the abdomen to stimulate the vagus nerve, which signals to the brain that the stomach is empty or full. Patients and doctors can adjust the device settings using external controllers. 

FDA Approves Cytori's Scleroderma Trial

January 12, 2015 8:15 am | News | Comments

Cytori Therapeutics announced today that the Center for Biologics Evaluation and Research, a division of the FDA, has given final approval to its application for an Investigational Device Exemption to begin a pivotal trial to evaluate Cytori Cell Therapy™ as a potential treatment for impaired hand function in scleroderma.

FDA Approves Daiichi Sankyo's Once-Daily SAVAYSA

January 9, 2015 8:21 am | News | Comments

Daiichi Sankyo Company today announced that the FDA has approved SAVAYSA Tablets, an oral, once-daily selective factor Xa-inhibitor, to reduce the risk of stroke and systemic embolism (SE) in patients with non-valvular atrial fibrillation (NVAF).

FDA Approves Impax Pharmaceuticals’ RYTARY for the Treatment of Parkinson's Disease

January 8, 2015 8:12 am | News | Comments

Impax Pharmaceuticals today announced that the FDA approved RYTARY, an extended-release oral capsule formulation of carbidopa-levodopa, for the treatment of Parkinson's disease, post-encephalitic parkinsonism, and parkinsonism that may follow carbon monoxide intoxication and/or manganese intoxication.

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FDA Approves Aethlon Medical's Ebola Treatment Protocol

January 2, 2015 3:58 pm | News | Comments

Aethlon Medical announced that the FDA has approved a clinical protocol to treat Ebola-infected individuals in the U.S. with the Aethlon Hemopurifier®. The device targets antiviral drug resistance and serves as a first-line countermeasure against Ebola and other viruses that are not addressed with proven drug therapies.

FDA Drug Approvals Reached 18-Year High in 2014

January 2, 2015 11:35 am | by MATTHEW PERRONE, AP Health Writer | News | Comments

The Food and Drug Administration approved 41 first-of-a-kind drugs in 2014, including a record number of medicines for rare diseases, pushing the agency's annual tally of drug approvals to its highest level in 18 years.     

FDA Approves Hospira’s Dyloject Injection

January 2, 2015 8:30 am | News | Comments

Hospira has received approval from the FDA for Dyloject Injection, a proprietary nonsteroidal anti-inflammatory drug analgesic.  Dyloject is indicated for use in adults for the management of mild to moderate pain and for the management of moderate to severe pain alone or in combination with opioid analgesics.

Actavis and Adamas Announce FDA Approval of Namzaric for Alzheimer’s Disease

December 24, 2014 8:38 am | News | Comments

Actavis and Adamas Pharmaceuticals announced that the FDA has approved the NDA for Namzaric, a fixed-dose combination of memantine hydrochloride extended-release, a NMDA receptor antagonist, and donepezil hydrochloride, an acetylcholinesterase inhibitor.

FDA Approves Novo Nordisk's Weight Loss Drug Saxenda

December 24, 2014 8:06 am | News | Comments

The drug, liraglutide, will be marketed under the brand name Saxenda. It is approved for obese adults and for overweight adults who have at least one weight-related health problem like type 2 diabetes, high blood pressure, or high cholesterol. 

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Teva’s GRANIX® Injection Approved for Self-Administration

December 23, 2014 8:17 am | News | Comments

Teva Pharmaceutical has announced that the FDA has approved GRANIX® Injection for self-administration by patients and caregivers. With the approval of this additional administration option, physicians will soon have the flexibility to prescribe GRANIX for either in-office or at home use.

Galderma Receives FDA Approval for Rosacea Treatment

December 23, 2014 8:04 am | News | Comments

Galderma Laboratories announced that the FDA approved Soolantra® Cream, 1% for the once-daily topical treatment of inflammatory lesions, or bumps and pimples, of rosacea. Rosacea is a common, but often misunderstood, skin disorder affecting 16 million Americans, predominantly women, ages 30 and older.

FDA Approves BMS' Melanoma Drug

December 22, 2014 4:30 pm | News | Comments

The agency approved Opdivo for patients with hard-to-treat melanoma that cannot be removed through surgery or has spread throughout the body. The approval was based on preliminary studies showing the drug helped shrink tumors in some patients. 

FDA Approves BioCryst's Oral Flu Drug Rapivab

December 22, 2014 11:33 am | News | Comments

Rapivab is a single-dose drug, and BioCryst said it is the first new antiviral influenza treatment to get marketing approval in 15 years. The drug is intended for patients who are too sick to take oral flu drugs.       

AstraZeneca Cancer Drug, Companion Test Approved

December 22, 2014 8:28 am | by LINDA A. JOHNSON, AP Business Writer | News | Comments

The FDA granted accelerated approval to the first in a new class of targeted drugs for ovarian cancer, Lynparza from British drugmaker AstraZeneca. The FDA also approved a companion diagnostic test from Myriad Genetics. The test is to be used to identify women most likely to benefit from the new medication.

Jazz Pharmaceuticals Receives FDA Approval for Intravenous Administration of Erwinaze

December 22, 2014 8:23 am | News | Comments

Jazz Pharmaceuticals has announced that the FDA approved the intravenous administration of Erwinaze.  Erwinaze is indicated as a component of a multi-agent chemotherapeutic regimen for the treatment of patients with acute lymphoblastic leukemia who have developed hypersensitivity to E. coli-derived asparaginase.

FDA Approves AbbVie Combo Hepatitis C Treatment

December 22, 2014 8:19 am | by LINDA A. JOHNSON, AP Business Writer | News | Comments

Patients with chronic hepatitis C have a new option for treating the liver-damaging virus, with the approval of a combination treatment developed by AbbVie. It includes a combination pill, which contains the antiviral drugs ombitasvir, paritaprevir and ritonavir, along with a tablet of dasabuvir. All the ingredients are new except for ritonavir, which works to increase blood levels of paritaprevir.

FDA OKs Cubist Antibiotic for Serious Infections

December 22, 2014 8:13 am | by LINDA A. JOHNSON, AP Business Writer | News | Comments

The FDA has approved a new medicine to fight complex infections in the abdomen and urinary tract, the fourth antibiotic the agency has approved since May. Zerbaxa treats serious and resistant bacteria, such as E.coli, that can cause life-threatening infections.

European Commission Approves Lynparza™ for Advanced BRCA-Mutated Ovarian cancer

December 18, 2014 9:04 am | News | Comments

AstraZeneca today announced that the European Commission has granted Marketing Authorization for Lynparza™ capsules as the first therapy for the maintenance treatment of adult patients with platinum-sensitive relapsed BRCA-mutated high grade serous epithelial ovarian, fallopian tube, or primary peritoneal cance.

Alcon's Xtoro Approved to Treat Swimmer’s Ear

December 17, 2014 4:17 pm | News | Comments

The FDA has approved Xtoro (finafloxacin otic suspension), a new drug used to treat acute otitis externa, commonly known as swimmer’s ear. Acute otitis externa is an infection in the outer ear and ear canal, usually caused by bacteria in the ear canal.

FDA Approves Pathogen Reduction System to Treat Plasma

December 17, 2014 10:24 am | News | Comments

The FDA has approved the Intercept Blood System for plasma, the first pathogen reduction system for use by blood establishments in the preparation of plasma in order to reduce the risk of transfusion-transmitted infections (TTI).    

FDA Approves Ipsen's Somatuline® Depot® Injection for the Treatment of Gastroenteropancreatic Neuroendocrine Tumors

December 17, 2014 8:23 am | News | Comments

Ipsen Biopharmaceuticals announced that Somatuline® Depot® Injection 120 mg (referred to as Somatuline®) was approved by the FDA for the treatment of gastroenteropancreatic neuroendocrine tumors (GEP-NETs) in adult patients with unresectable, well or moderately differentiated, locally advanced or metastatic disease to improve progression-free survival.

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