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 - 10:12The 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 - 10:03Food 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.”
New Data Submitted to FDA by Merck for Wider Use of Gardasil
Submitted by Tangaroa Snell on Thu, 01/14/2010 - 20:28
On Wednesday, pharmaceutical company Merck & Co. confirmed that it has submitted new clinical data to the US Food and Drug Administration, with the hope that it will be allowed the expanded use of Gardasil, the cervical-cancer vaccine, in women who are aged between 27 and 45.
Roche's Actemra Arthritis Drug Gains FDA Approval
Submitted by Tangaroa Snell on Sun, 01/10/2010 - 14:23
As was confirmed by the company on Friday, the US Food and Drug Administration has awarded its approval to Roche Holding's Acterma drug, which has been developed to treat rheumatoid arthritis.
The medicine, manufactured by Roche's Genentech unit, already has approval for use and marketing in Europe and Japan and is expected by the firm to be yet another blockbuster product.
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