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Barr Submits Plan B Response To FDA, Starts 180-Day Review Clock

This article was originally published in The Tan Sheet

Executive Summary

An FDA decision on OTC availability of Barr Labs' Plan B emergency contraceptive is expected by the end of January

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Plan B sNDA

PDUFA decision date for Plan B OTC supplemental NDA is Jan. 20, Barr says at Banc of America Securities conference in San Francisco, Sept. 23. The Woodcliff Lake, N.J.-based generics firm submitted "information supporting the marketing of Plan B as a prescription-only product for women 15 years of age and younger and a nonprescription product for women 16 years of age and older," Barr said in July (1"The Tan Sheet" July 26, 2004, p. 5)...

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