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FDA to allow continued availability of Shire's ProAmatine, generic formulations, reversing earlier decision to withdraw products
Tuesday, September 07 2010 | Comments
What's This?
The Food and Drug Administration indicated that, for now, it will not pursue the withdrawal of Shire US Inc.'s ProAmatine (midodrine hydrochloride) and generic formulations of the drug from the market, despite its proposal last month to do so. The agency called for withdrawal of the products, which are used to treat orthostatic hypotension, because the manufacturers have not provided evidence confirming the drugs' benefit.
ProAmatine was approved in 1996 under the FDA's accelerated approval regulations for drugs that are used to treat serious or life-threatening diseases. The approval required Shire to conduct postapproval studies to verify the drug's clinical benefit. However, neither Shire nor any of the companies that market generic formulations of the agent, including Apotex Corp., Impax Laboratories Inc., Mylan Pharmaceuticals Inc., Sandoz Pharmaceuticals Inc. and Upsher-Smith Laboratories Inc., has conducted any postapproval studies.
Since the FDA's proposal was announced last month, the agency has received "numerous" communications from health care providers and patients who find the treatment to be effective, Sandy Walsh of the FDA's Office of Public Affairs told VerusMed in an e-mailed statement. Consequently, the FDA decided to maintain continued availability of ProAmatine and the generic formulations as it sorts through the legal issues requiring additional studies.
The law states that clinical studies must be completed and supporting efficacy data must be submitted to the FDA, Walsh emphasized, noting that "the law ... still stands."
After the FDA announced its proposal, Shire said it would withdraw ProAmatine from the market effective Sept. 30. However, Shire no longer plans to do so, in light of the FDA's decision to allow continued availability of the drug while the agency evaluates the situation, The Associated Press reported.
The FDA actions related to ProAmatine and the generic formulations mark the first time the agency has taken steps to withdraw marketing approval for a drug approved under the accelerated approval regulations.
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