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U.S. FDA seeks additional info on drug from Richter partner

History

Pharmaceuticals firm Gedeon Richter says that the U.S. Food and Drug Administration (FDA) has requested additional information from its partner Allergan in response to the latterʼs New Drug Application (NDA) for ulipristal acetate (UPA) for the treatment of uterine fibroids. UPA is the active ingredient of Richterʼs drug Esmya.

The FDA said it is not able to approve the ulipristal acetate NDA in its current form, according to Hungarian news agency MTI. The agency cited safety concerns regarding Esmya post-marketing reports outside the United States. Allergan plans to meet with the FDA to discuss their comments and the next steps. 

The European Commission (EC) made a resolution at the end of July regarding the distribution of Esmya after the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion on the matter on June 1. The EC specified amended conditions for the drugʼs distribution license.

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