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Updated Plan B Lawsuit Could Expand Emergency Contraceptive Switch Targets

This article was originally published in The Pink Sheet Daily

Executive Summary

The Center for Reproductive Rights plans to revise its 2005 complaint against FDA seeking OTC access to emergency contraceptives. In addition to adding HHS Secretary Sebelius as a defendant, CRR may ask for OTC sales of second-generation Plan B One-Step since the original product is available only as generics.

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Teva Plan B OTC Application Fails Political Test After Clearing FDA Hurdle

HHS Secretary Sebelius says Teva must show more evidence of how young adolescent females would use Plan B One-Step as an OTC. But obtaining such clinical data for the emergency contraceptive – in excess of what FDA already needed to approve it – appears nearly impossible, experts say.

FDA Will Wait To Act On Plan B Petition Despite Contempt Complaint

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With Exclusivity For Single-Dose Plan B, Teva Stays One Step Up On Generics

Teva Pharmaceutical Industries likely will gain another three years of exclusivity in the branded nonprescription emergency contraceptive market with FDA's approval of a revised dosage of Plan B

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