The suggestion of U.S panel of experts regarding diet drug Acomplia not to be sold in the United States resulted in to a review of safety data Medicines Agency (EMEA) next week
EMEA had approved the diet drug acomplia last year in the European Union and til now
The diet drug is prescribed to more than 100000 people.
However, the FDA briefing June 13th of its Endocrinologic and Metabolic Drugs Advisory Committee included safety data submitted after European authorities approved Acomplia, and the strong concern expressed by the U.S. panel seems likely to lead to a more than routine review by European regulators.
A regular meeting of the EMEA's Committee for Medicinal Products for Human
Use (CHMP) is set for June 18-21 and a spokesperson said Acomplia will "surely" be on the agenda in view of the serious safety concerns raised by the FDA experts.
A meeting of the EMEA's Committee for Medicinal Products for Human
Use (CHMP) has been scheduled on June 18-21 and safety concern raised by the FDA experts will be the main issue regarding acomplia.
A few people are thinking that acomplia will be pulled out from European market or it may be happened the changing of label of drug or the prescription guidance or issuing additional warnings could come at the end of next week.
It is not required to follow the recommendations of its advisory panels by the FDA. the agency almost certainly will decide next month to defer action on Acomplia and await more data
Thursday, June 14, 2007
Acomplia safety data to be reviewed
Subscribe to:
Post Comments (Atom)
No comments:
Post a Comment