8-Sep-10 9:00 AM CST
FDA Reverses Notice to Withdraw ProAmatine
The FDA has changed its mind on its notice to withdraw ProAmatine from the market, prompting ProAmatine’s manufacturer Shire to reverse its plans to remove the drug by the end of September, the Associated Press reported Monday.
Shire had originally planned to withdraw ProAmatine (midodrine) by the end of September when the FDA itself threatened to remove the drug last month. In a statement made by the FDA about the notice, the agency said it was because Shire had failed to submit required post-market study data verifying the drug’s benefits. Shire had said in a response statement that it did conduct post-market studies and had submitted the data to the FDA, but the agency did not accept the data, citing that it was inconclusive.
ProAmatine is a blood pressure treatment for symptomatic orthostatic hypotension, a condition where a person experiences a sudden drop in blood pressure when standing up, causing dizziness and fainting. It received accelerated approval for its potential to produce measurable clinical benefits such as improved survival or decreased severity of a disease. All drugs that receive accelerated approval are required to have follow-up studies conducted to verify their perceived clinical benefits and then submitted to the FDA.
FDA spokeswoman Sandy Walsh told the Associated Press that although the FDA has removed the notice on ProAmatine, the issue is far from over. The agency will be working with Shire in the coming weeks for a resolution.
Patients can continue taking ProAmatine and its generic equivalent midodrine.
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Tags: CPhT FDA generic market withdrawal midodrine NPTA orthostatic hypotension pharmaceuticals pharmacy pharmacy technician ProAmatine Shire
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