Plan B sNDA
This article was originally published in The Tan Sheet
Executive Summary
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)...