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US FDA Requests More Information, Needs More Time To Review Birth Control OTC Switch Proposal

 
• By Malcolm Spicer

FDA decision on Perrigo subsidiary’s proposal for first US OTC daily oral contraceptive is extended 90 days with the postponement of an advisory panel meeting. Agency requested additional information related to OTC switch application of 0.075-mg norgestrel initially submitted in July.

• Source: Shutterstock

The deadline for US regulators’ decision on Perrigo Company PLC subsidiary HRA Pharma’s proposal for the country’s first OTC a daily oral contraceptive is extended 90 days with the postponement of an advisory panel meeting.

The reason for putting off a joint meeting scheduled on 18 November for the Food and Drug Administration’s Nonprescription Drugs and Obstetrics, Reproductive and Urologic Drugs advisory committees to discuss...

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