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Pharmaceuticals / Regulatory Affairs / Postmarket Safety / Submissions and Approvals

FDA Withdraws Applications for Products Containing Phenylpropanolamine

Feb. 20, 2014

The FDA is officially withdrawing 13 NDAs and seven ANDAs for products containing phenylpropanolamine (PPA), a Federal Register notice published today states.

The withdrawals are based on evidence from spontaneous reports of hemorrhagic strokes occurring in patients who had taken prescription and over-the-counter drugs containing PPA. The withdrawals also follow recent results from a study done by the Yale Hemorrhagic Stroke Project showing that “phenylpropanolamine is not shown to be safe for use under the conditions of use that formed the basis upon which the applications were approved,” the agency says.

PPA was mostly found in decongestants and in appetite-suppressing weight loss drugs, none of which remain on the market, the FDA confirmed. The applications in question will be removed from the agency’s list of drug products with effective approvals and no new applications containing PPA will be accepted.

View the Federal Register notice at www.fdanews.com/ext/resources/files/02/02-20-14-Applications.pdf. — Lena Freund

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