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 The leading web portal for pharmacy resources, news, education and careers August 28, 2014
Pharmacy Choice - News - U.S. FDA Final Approvals (Drugs & Devices) - August 28, 2014

Pharmacy News

 U.S. FDA Final Approvals (Drugs & Devices)
Current Articles | 7 - 30 Days Old | 30 - 90 Days Old | Over 90 Days
Articles(s): 1 - 13 of 13     Go To Page:

8/27/14 - FDA Approves Genentech's Avastin Plus Chemotherapy for Treatment of Advanced Cervical Cancer
By a News Reporter-Staff News Editor at Biotech Week Genentech, a member of the Roche Group, announced that the U.S. Food and Drug Administration approved Avastin in combination with paclitaxel and cisplatin or paclitaxel and topotecan for the treatment of women with persistent, recurrent or metastatic carcinoma of the cervix. "With this appr
8/25/14 - BioTime Receives FDA Premarket Notification Clearance for Premvia? 510k
By a News Reporter-Staff News Editor at AIDS Weekly BioTime, Inc. announced that it has received notice from the FDA's Center for Devices and Radiologic Health that Premvia? has been cleared for marketing as a Class II medical device. Premvia? is the first FDA- cleared member of BioTime's HyStem family of hydrogels, which are designed to m
8/25/14 - FDA Approves BELSOMRA suvorexant for the Treatment of Insomnia
By a News Reporter-Staff News Editor at Clinical Trials Week Merck, known as MSD outside the United States and Canada, announced that the U.S. Food and Drug Administration has approved BELSOMRA for adults with insomnia who have difficulty falling asleep and/or staying asleep. BELSOMRA is a highly selective antagonist for orexin receptors.
8/25/14 - FDA Approves Exact Sciences' Cologuard; First and Only Stool DNA Noninvasive Colorectal Cancer Screening Test
By a News Reporter-Staff News Editor at Managed Care Weekly Digest Exact Sciences Corp. announced that the U.S. Food and Drug Administration has approved Cologuard, the company's noninvasive, stool DNA colorectal cancer screening test. Upon approval, Exact Sciences also received a proposed coverage memorandum from the Centers for Medicare and Med
8/23/14 - FDA Approves The Medicines Company's ORBACTIV? oritavancin for Use in Acute Bacterial Skin and Skin Structure Infections
By a News Reporter-Staff News Editor at Obesity, Fitness& Wellness Week The Medicines Company announced that the U.S. Food and Drug Administration has approved ORBACTIV? for injection for the treatment of adults with acute bacterial skin and skin structure infections caused by susceptible designated Gram-positive bacteria including...
8/22/14 - Mylan Launches First Generic Klor-Con Extended-Release Tablets
Mylan Inc. today announced that it has launched Potassium Chloride Extended-release Tablets USP, 8 mEq and 10 mEq, which is the generic version of Upsher-Smith's Klor-Con . Mylan received final approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application for this product, which is indicated for the treatment of p
8/22/14 - PFIZER -U.S. FDA Approves Eliquis (apixaban) for the Treatment of Deep Vein Thrombosis (DVT) and Pulmonary Embolism (PE), and for the Reduction in the Risk of Recurrent DVT and PE Following Initial Therapy
Release date- 21082014- Bristol-Myers Squibb Company and Pfizer Inc. today announced the U.S. Food and Drug Administration has approved a Supplemental New Drug Application for Eliquis for the treatment of DVT and PE, and for the reduction in the risk of recurrent DVT and PE following initial therapy. 'We are pleased that Eliquis is now available as
8/22/14 - Tekmira Up On Positive Ebola-Related Drug Study; Philips Receives FDA 510(k) Clearance For TAVI
The application features a comprehensive measurement package to accommodate virtually all types of TAVI devices. "As our population ages, minimally invasive TAVI procedures are becoming increasingly popular in the United States, since they provide a non-surgical option for those patients who might have once been considered too high-risk for heart..
8/22/14 - United States : Amerigen Pharmaceuticals Ltd. announces that its Chinese subsidiary, Suzhou Amerigen Pharmaceuticals Co. Ltd., has received Chinese... [TendersInfo (India)]
United States: Amerigen Pharmaceuticals Ltd. announces that its Chinese subsidiary, Suzhou Amerigen Pharmaceuticals Co. Ltd., has received Chinese FDA approval and has subsequently launched it. Amerigen Pharmaceuticals Ltd. announces that its Chinese subsidiary, Suzhou Amerigen Pharmaceuticals Co. Ltd., has received Chinese FDA approval and has...
8/21/14 - FDA Approves Eliquis For Treatment Of Deep Vein Thrombosis, Pulmonary Embolism
NEW YORK CITY- Bristol-Myers Squibb Co. and Pfizer Inc. said Thursday that the U.S. Food and Drug Administration has approved a Supplemental New Drug Application for Eliquis for the treatment of deep vein thrombosis and pulmonary embolism, and for the reduction in the risk of recurrent DVT and PE following initial therapy. Combined, DVT and PE are
8/21/14 - FDA clears Eliquis for new use against blood clots
WASHINGTON Bristol-Myers Squibb and Pfizer said Thursday that federal regulators have expanded approval of their blood thinner Eliquis to treat two types of dangerous blood clots. The Food and Drug Administration cleared the drug for patients suffering from or at risk of deep vein thrombosis and pulmonary embolism. Eliquis, known chemically as a
8/21/14 - Intuitive Surgical Receives Firefly(TM) FDA Clearance for da Vinci(R) Xi(TM) Surgical System
Intuitive Surgical, Inc., the global leader in robot-assisted minimally invasive surgery, today announced the FDA clearance of Firefly Fluorescence Imaging for the da Vinci Xi? Surgical System, which provides surgeons with enhanced visualization during minimally invasive surgical procedures. Firefly Imaging has been available since 2011 as a
8/21/14 - U.S. FDA Approves Eliquis (apixaban) for the Treatment of Deep Vein Thrombosis (DVT) and Pulmonary Embolism (PE), and for the Reduction in the Risk of Recurrent DVT and PE Following Initial Therapy
PRINCETON, N.J.& NEW YORK Bristol-Myers Squibb Company and Pfizer Inc. today announced the U.S. Food and Drug Administration has approved a Supplemental New Drug Application for Eliquis for the treatment of DVT and PE, and for the reduction in the risk of recurrent DVT and PE following initial therapy. Combined, DVT and PE are known as VTE.
Articles(s): 1 - 13 of 13     Go To Page:


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