Barr Submits Plan B Response To FDA, Starts 180-Day Review Clock
This article was originally published in The Tan Sheet
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 comment analysis is being handled by an outside contractor with oversight by FDA's Office of Policy, according to Acting Commissioner Andrew von Eschenbach, MD
Availability and use of nonprescription emergency contraception by young women did not result in increased sexual activity, according to a study in the Jan. 5 Journal of the American Medical Association
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)...