Pharmacy News

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FDA News

2/9/10 - Amneal Pharmaceuticals wins FDA approval for pain drug

Amneal Pharmaceuticals, a developer of generic pharmaceuticals, has received the FDA's approval to manufacture combination tramadol HCl in 37.5mg strength and acetaminophen in 325mg strength in tablet form. Amneal's generic is an AB-rated, therapeutically equivalent alternative to Ultracet, a licensed trademark of Ortho-McNeil Janssen.

2/9/10 - Medical Acoustics Receives FDA 510k Clearance of Therapeutic Lung FluteÂ®

Medical Acoustics LLC, a commercial-stage medical device company which employs acoustic technologies for diagnostic and therapeutic medical applications, announced that it has received FDA 510 clearance of its Therapeutic Lung FluteÂ®. The application follows the successful completion of a clinical trial at the University at Buffalo and the Western

2/9/10 - Sorin wins FDA approval for Paradym CRT defibrillator

Sorin Group, a medical device company, has announced the FDA approval and first implant of its next-generation of cardiac resynchronization therapy defibrillator, or CRT-D, Paradym CRT Model 8750. Featuring a new battery technology, Paradym CRT reportedly delivers 37 joules, the highest energy of any implantable cardiac defibrillator currently avai

2/9/10 - US FDA Approves New Indication for CRESTOR(R) (rosuvastatin calcium)

WILMINGTON, Del., Feb. 8AstraZeneca today announced that the US Food and Drug Administration has approved CRESTORÂ® to reduce the risk of stroke, myocardial infarction and arterial revascularization procedures in individuals without clinically evident coronary heart disease but with an increased risk of cardiovascular disease based on age, high-sen

2/9/10 - Volcano Receives FDA Clearance to Market the Eagle Eye(R) Platinum Digital IVUS Catheter

SAN DIEGO, Feb. 9Volcano Corporation, a leading developer and manufacturer of precision intravascular therapy guidance tools designed to enhance the diagnosis and treatment of coronary and peripheral vascular disease, announced today that it has received 510 clearance from the U.S. Food and Drug Administration to market the Eagle EyeÂ® Platinum dig

2/9/10 - YM BioSciences announces FDA clearance for two ongoing Phase II nimotuzumab trials into USA

YM BioSciences Inc., announced that the FDA has advised the Company that it may now enroll patients at US clinical sites into two ongoing randomized, double-blind Phase II trials of its lead product, nimotuzumab. The current trial designs were informed by previous trials with nimotuzumab in the same indications.

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