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Opill AdCom Delay Not Unusual – Will Evaluation Of US OTC Switch Proposal Continue In The Norm?

 
• By Malcolm Spicer

Whether FDA handling of HRA Pharma’s OTC switch NDA for 0.075-mg norgestrel continues along normal arc is question which prompts concerns. “I hope that they don't make the same mistakes that were made back on the Plan B,” says Susan Wood, an associate professor at George Washington University School of Public Health and a former FDA office director.

• Source: Shutterstock

The US Food and Drug Administration’s request for additional information from the sponsor of a proposal for the country’s first OTC daily oral contraceptive wasn’t unusual as a part of the agency’s evaluation of new drug applications.

However, whether the FDA’s handling of HRA Pharma’s OTC switch NDA for 0.075-mg norgestrel, a progestin-only formulation branded Opill, continues...

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