Like Plan B, Approval For OTC Daily Oral Contraceptives In US Could Be An 'Adventure’
It was only after prolonged litigation led a federal judge in 2013 to order FDA not to allow political interference with its science-based decisions that Plan B and generic equivalents became available OTC without age restrictions. “Hopefully, all I can say, it won't happen again,” says reproductive rights advocate Kirsten Moore.
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HRA’s approval for pharmacy sales of a daily oral contraceptive the UK and its ongoing work on an NDA to propose making another progestin-only contraceptive ingredient available OTC in the US stand out as additions to Perrigo’s business with the most substantial revenue impacts.
The UK's MHRA has approved the Rx-to-OTC switch of two identical progestogen-only contraceptive pills from HRA Pharma and Maxwellia. Hana and Lovima (both 75mcg desogestrel) will be launched at the end of the month.
Under a federal judge’s order, FDA must reverse its denial of the Center for Reproductive Rights’ 12-year-old citizen petition and allow universal OTC access to Plan B One-Step and equivalent levonorgestrel-based emergency contraceptives within 30 days.