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Plan B Rx-to-OTC switch

This article was originally published in The Tan Sheet

Executive Summary

Nonprescription Drugs and Reproductive Health Drugs advisory committees will convene Dec. 16 to "consider the safety and efficacy of NDA 21-045, proposing OTC use of Plan B...for reducing the chance of pregnancy after unprotected sex if contraceptive failed, or birth control was not used." Meeting will begin at 8 A.M. at the Hilton, 620 Perry Parkway, Gaithersburg, Md. Women's Capital Corporation filed the switch application for the emergency contraceptive in April 2003. Barr Labs announced signing a letter of intent to purchase Plan B from WCC Oct. 2. Barr expects a definitive agreement to be reached by mid-November and says the acquisition will not affect efforts to switch the drug OTC (1"The Tan Sheet" Oct. 6, 2003, p. 3)...

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