May 16 (Reuters) - U.S. regulators will ask outside experts if the agency should revoke approval of Abbott Laboratories Inc's (ABT.N) heart medicine Trilipix for use with a cholesterol-lowering statin drug, according to draft questions released on Monday.
Other actions for the advisory panel to consider are allowing continued marketing of Trilipix with a statin while adding results of a study known as Accord-Lipid to the drug label, or making no label changes.
The Accord-Lipid study found combining a similar drug, TriCor, with a statin failed to reduce heart attacks and other cardiac problems. Major heart problems increased for women in the trial, the FDA said when it announced the panel meeting.
The panel of outside experts will give recommendations on Trilipix on Thursday. The FDA is not required to follow panel advice but usually does.
Sales of TriCor and Trilipix totaled $1.5 billion in 2010. Removing approval for Trilipix use with a statin could hurt sales of the Abbott drug. (Reporting by Lisa Richwine, editing by Bernard Orr)
Tuesday, May 17, 2011
Adding Abbott's Trilipix to statin gets US FDA scrutiny | Reuters
via reuters.com
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Great content ! specially """"the Accord-Lipid study found combining a similar drug, TriCor, with a statin failed to reduce heart attacks and other cardiac problems"""
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