February 4, 2012
Pharmacy news, jobs, continuing education, community and more.
Bristol-Myers Squibb Company (NYSE: BMY) and Pfizer Inc. (NYSE: PFE) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review a New Drug Application (NDA) for ELIQUIS® (apixaban), an investigational compound for the prevention of stroke and systemic embolism in patients with atrial fibrillation. The FDA accepted the filing and assigned [...]
Abbott (NYSE: ABT) received approval from the U.S. Food and Drug Administration (FDA) for a new Chagas in vitro diagnostic test. The ABBOTT ESA Chagas is the first FDA-approved supplemental test that detects antibodies to Trypanosoma cruzi (T. cruzi), a parasite found only in the Americas and commonly acquired through contact with the blood-sucking triatomine, [...]
The National Foundation for Celiac Awareness (NFCA) is proud to announce that the organization has been awarded a $50,000 grant from The Food and Drug Administration (FDA) to fund the first scientific research in the area of gluten in medication. The project entitled, “Gluten in Medication: Qualifying the extent of exposure to people with celiac [...]
To sustain medical innovation, the FDA must accelerate the adoption of a Benefit-Risk framework to inform decision-making in the regulatory process, said John Lechleiter, Ph.D., chairman, president and CEO of Eli Lilly and Company (NYSE: LLY). In an address at the FDA News Fourth Annual Risk Management and Drug Safety Summit, Lechleiter called for a [...]
Abbott (NYSE: ABT) today announced it has received U.S. Food and Drug Administration (FDA) approval for the next-generation XIENCE PRIME(TM) Everolimus Eluting Coronary Stent System for the treatment of coronary artery disease. With the introduction of XIENCE PRIME in the United States, Abbott, the worldwide leader in drug eluting stent technology, now offers physicians an [...]
Bristol-Myers Squibb Company (NYSE: BMY) and AstraZeneca (NYSE: AZN) announced today that the U.S. Food and Drug Administration (FDA) has extended the action date for dapagliflozin for the treatment of type 2 diabetes by three months. The new Prescription Drug User Fee Act (PDUFA) goal date is January 28, 2012. “Bristol-Myers Squibb and AstraZeneca are [...]
NEW YORK – Pfizer Inc. (NYSE: PFE) and the National Association of Boards of Pharmacy® (NABP) are launching a new effort to draw attention to the risks associated with counterfeit prescription medicines and help patients learn how to safely buy medicines online. Prescription medicines are among the most counterfeited consumer goods. Worldwide sales of counterfeit [...]
Hope Pharmaceuticals today announced the launch of Nithiodote© (co-packaged Sodium Nitrite Injection, USP and Sodium Thiosulfate Injection, USP), a new antidote indicated for the treatment of acute cyanide poisoning that is judged to be life-threatening. Because the introduction of new antidotes for the treatment of chemical threats can enhance public safety and homeland security, the [...]
ABBOTT PARK, Ill., – Abbott (NYSE: ABT) announced today that the U.S. Food and Drug Administration (FDA) has approved two new strengths for three-month administration of Lupron Depot-PED ® (leuprolide acetate for depot suspension) for the treatment of children with central precocious puberty (CPP). CPP is a condition that causes children to enter puberty too [...]
PRINCETON, N.J. & WILMINGTON, Del. – Bristol-Myers Squibb Company (NYSE: BMY) and AstraZeneca (NYSE: AZN) today reported the outcome of the U.S. Food and Drug Administration’s (FDA) Endocrinologic and Metabolic Drugs Advisory Committee meeting on the New Drug Application for the investigational compound dapagliflozin. “Do the efficacy and safety data provide substantial evidence to support [...]
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