FDA Withdraws Applications For Drugs With Phenylpropanolamine
The U.S. Food and Drug Administration (FDA) announced this week it is officially withdrawing applications for products containing the substance phenylpropanolamine (PPA). The FDA also said it will not accept new applications containing PPA.
The Federal Register notice issued today stated, “The Food and Drug Administration (FDA) is withdrawing approval of 13 new drug applications (NDAs) and 7 abbreviated new drug applications (ANDAs) for products containing phenylpropanolamine. The basis for the withdrawals is that the products are no longer considered safe due to the association of phenylpropanolamine use with increased risk of hemorrhagic stroke. The holders of these NDAs and ANDAs have waived their opportunity for a hearing.”
The FDA decision follows results from a published study conducted by Yale Hemorrhagic Stroke Project. The epidemiologic case control study demonstrated an association between PPA and increased risk of hemorrhagic stroke. PPA is commonly used as a nasal decongestant to relieve stuffy nose and OTC weight control drugs to control appetite. “The notice included FDA’s belief that the data from the Yale Hemorrhagic Stroke Project, taken together with spontaneous reports of hemorrhagic stroke and reports in the published medical literature, provided evidence that nasal decongestant and weight control drug products containing phenylpropanolamine are no longer safe. The Director proposed to withdraw approval of the NDA and ANDA products containing phenylpropanolamine based on her conclusion that they were no longer shown to be safe for use under the conditions that formed the basis upon which the applications were approved,” the FDA stated.
Product applications listed in the notice included Tavist-D Extended-Release Tablet by Novartis, Hycomine Syrup by Endo Pharmaceuticals, Contac Extended-Release Tablet by Novartis Consumer Health, and Bromatapp Extended-Release Tablet by Teva Pharmaceuticals, USA.
Pfizer has already requested withdrawal of NDA application for its product DIMETANE-DC containing PPA back in February 2013, saying that production of the drug has been discontinued and is no longer marketed.