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US FDA Has 10 Months To Provide Answer On Perrigo/HRA OTC Oral Contraceptive Application

 
• By Malcolm Spicer

Perrigo's HRA Pharma submits to FDA on 11 July an NDA by for OTC 0.075-mg norgestrel, branded Opill, The same formulation previously was available Rx 30 years. 

• Source: Shutterstock

US consumers could know in 10 months whether a daily oral contraceptive for the first time will be approved for OTC sales.

The question is posed to the Food and Drug Administration in a new drug application submitted on 11 July by Perrigo Company PLC business HRA Pharma to move 0.075-mg norgestrel, branded Opill, from Rx to OTC

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