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Plan B Pioneers OTC “Pharmacy Counter” Approval, Dual-Status Marketing

This article was originally published in The Tan Sheet

Executive Summary

FDA's decision to approve emergency contraceptive Plan B for over-the-counter sale to women age 18 and older cracks open the door on a pharmacy-only, behind-the-counter model for nonprescription drug sales

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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.

Barriers To US OTC Emergency Contraceptive Sales Remain Despite Court Rebuke Of Restrictions

Continuing impediments include pharmacists and other staff at drug and grocery stores refusing to sell emergency contraceptives, some stores stocking products in locked display cabinets and prices unaffordable to some consumers, says Kelly Cleland, American Society for Emergency Contraception executive director.

Gedeon Richter To Market HRA Pharma’s Novel Emergency Contraceptive, ellaOne

HRA expects to file an NDA for ellaOne in the U.S. by end of year.

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