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First OTC Oral Contraceptive Has Advisory Panel’s Unanimous Support Despite FDA’s Data Concerns

 
• By Malcolm Spicer

FDA officials again made clear concerns about “improbable dosing” data in HRA’s sNDA for 0.075-mg norgestrel tablet branded Opill before advisory panel voted at close of a two-day meeting conducted 60 years after first Rx oral contraceptive approved in US.

• Source: Shutterstock

Some members of a Food and Drug Administration advisory panel had questions and others didn’t about HRA Pharma’s actual user study data but all voted to recommend the agency approve the firm’s proposal for the first OTC switch of an oral contraceptive in the US.

FDA officials again made clear their concerns about “improbable dosing” data in HRA’s supplement new drug application for its 0.075-mg norgestrel tablet branded Opill before the panel voted on 10...

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