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HRA Proposes OTC Norgestrel Birth Control

 
• By Hannah Daniel

HRA has worked with Ibis Reproductive Health, which supports the Free the Pill advocacy group, to conduct research for a norgestrel switch NDA.

• Source: Shutterstock

HRA Pharma submitted the first new drug application in the US for an OTC oral contraceptive, proposing a re-launch of Opill (0.075 mg norgestrel) it previously marketed Rx with more than 50 years of successful and safe use preventing pregnancies.

The FDA approved Rx sales of Opill in 1973 as a progesterone-only daily birth control pill. HRA, a French pharma owned by Perrigo Company PLC, discontinued Opill sales in...

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