OPDP Issues Untitled Letter Over Major Statement Presentation
October 3, 2025 at 01:34 PM EST
After a flurry of Warning Letters and Untitled Letters signed by FDA Center for Drug Research and Evaluation Director George Tidmarsh in early September, the FDA’s Office of Prescription Drug Promotion (OPDP) issued an Untitled Letter Sept. 23 to Novartis Pharmaceuticals Corp. in East Hanover, N.J. over a direct-to-consumer broadcast ad for Fabhalta (iptacopan) capsules.
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