Concerns Over Risk Claims Prompt Untitled Letter for Speaker Deck

J.W. Schomisch
May 20, 2025 at 11:14 AM EST
The FDA’s Office of Prescription Drug Promotion (OPDP) sent an Untitled Letter to Mayne Pharma LLC in Raleigh, N.C., alleging a speaker deck for Nextstellis (drospirenone and estetrol tablets) contained “false or misleading claims” about product risks. The April 28 Untitled Letter was the result of a requested FDA review of a promotional communication. As has been the case in... Read More

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