WASHINGTON (Reuters) - U.S. health officials on Monday proposed withdrawing approval of a Shire Plc hypotension drug because the company failed to conduct post-approval studies.
The drug, ProAmatine, was approved in 1996 to treat orthostatic hypotension, a type of low blood pressure.
Generic makers of the medicine must stop selling their copycat versions if the Food and Drug Administration withdraws the approval. Generic manufacturers include Mylan Pharmaceuticals Inc and Novartis unit Sandoz.
About 100,000 U.S. patients filled prescriptions for brand or generic forms of the drug in 2009, the FDA said.
Officials at Shire could not immediately be reached for comment.
(Reporting by Lisa Richwine; Editing by Steve Orlofsky)
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