Boston Scientific Resumes Defibrillator Sales
Submitted by Ketan Mukherjee on Fri, 04/16/2010 - 22:11
The Boston Scientific Corporation on Thursday announced that the Food and Drug Administration had permitted it to resume defibrillator sales after a one-month halt due to the company's failure to notify regulators related to manufacturing changes to the devices.
FDA Requires Third Party Inspector to Meet Quality Standards
Submitted by Ketan Mukherjee on Thu, 03/25/2010 - 19:51
On Wednesday, Genzyme Corp. said that U. S. Food and Drug Administration would need a third party inspector to make sure that all the drug quality standards are met.
According to the news this afternoon, the shares of Genzyme had dropped by 4% at $55.25.
Novartis’s Menveo Gilenia gets FDA’s Approval
Submitted by Ketan Mukherjee on Mon, 02/22/2010 - 19:51
U. S. Food and Drug Administration has commended Novartis' meningococcal vaccine Menveo and granted priority review for its multiple sclerosis pill Gilenia.
As per the estimations of the analysts, both the products have immense potential and its yearly sales may reach $1bn mark in the next few years.
The company claims that Menveo can be given to people from different age groups.
FDA Announces Inadequate Clinical Data on Proposed Cancer Drug Pixantrone
Submitted by Ketan Mukherjee on Mon, 02/08/2010 - 22:37
The Food and Drug Administration on Monday announced that there was insufficient clinical evidence involving a proposed Cell Therapeutics, Inc. drug that would treat non-Hodgkin's lymphoma, and revealed that the medicine significantly posed side effects, according to documents released.
Drug for multiple sclerosis gets FDA approval
Submitted by Ketan Mukherjee on Sun, 01/24/2010 - 10:12
The FDA on Friday approved a drug named Ampyra; its generic name is dalfampridine, to improve walking speed of people with multiple sclerosis. It is first of its kind to receive FDA approval.
Levy who was unable to walk and was frustrated after taking every possible treatment for MS had become frustrated. It was then that Levy’s neurologist discussed the possibility of trying 4-aminopyradine, a version of the drug that the FDA approved on Friday. She took the drug for three days and was able to walk without any help.
Bogus Glaxo diet drug in sale
Submitted by Ketan Mukherjee on Sun, 01/24/2010 - 10:03
Food and Drug Administration officials on Saturday warned that GlaxoSmithKline's fake versions of over-the-counter diet pill called Alli contained high levels of a prescription weight loss ingredient called sibutramine that was dangerous.
Dr Janet Woodcock, head of the FDA's drug unit, told reporters that "The amount of sibutramine in the counterfeit Alli poses a serious health risk to some individuals. A person taking the counterfeit Alli as directed would be exposed to twice the maximum prescription dose of sibutramine every day.”
