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Pharmaceuticals / Inspections and Audits

FDA Clears Up Labeling Situation for Sprout Pharma’s Female Libido Drug

Sept. 23, 2019

The FDA said it did not approve labeling and REMS changes for Sprout Pharmaceuticals’ female hypoactive sexual desire disorder drug, Addyi (flibanserin), despite a press release from the company to that effect.

In April, Sprout appealed to get an agency-ordered alcohol contraindication removed from the drug’s labeling and alcohol-related restrictions removed from the REMS. Sprout claimed the Office of New Drugs agreed with its points at the end of the appeal process.

But the FDA asked Sprout to withdraw the press release and reached out to media outlets to explain that the changes have not yet been cleared.

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