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

Executive Summary

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. 

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First OTC Birth Control Pill Approved In US Will Launch With Three-Year Market Exclusivity

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