FDA proposes to remove Shire Low Blood Pressure drug from the market

Shire’s low blood pressure drug, ProAmatine, along with its 5 generic forms (by: Apotex Corp., Impax Laboratories Inc., Mylan Pharmaceuticals, Sandoz Inc., and Upsher-Smith Laboratories) are being considered for withdrawal by the FDA after the companies failed to show any follow-up data, despite receiving a request for 2 follow-up studies from FDA last year. ProAmatine was approved in 1996 under the accelerated approval process which grants early approval for drugs that show efficacy for serious, life-threatening conditions but also requires companies to follow up with post-marketing data to prove how the drug works.

Interestingly, Shire responded by stating that the follow-up studies they conducted were considered inconclusive by FDA and that the company notified FDA about withdrawing their NDA for ProAmatine, citing low revenues from the drug, back in November 2009. Read more here: Shire’s response to FDA’s proposal to withdraw ProAmatine

It will be interesting to see, in the days that follow, if FDA will continue cracking down on post-marketing commitments and how pharmaceutical companies will react to FDA’s actions.

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