FDA approves OTC Plan B One-Step for all ages

FDA approved a supplemental application from Teva Pharmaceutical Industries Ltd. (NYSE:TEVA) to expand the label of OTC Plan B One-Step levonorgestrel to include all women of child-bearing potential. FDA said the approval of the single-dose formulation emergency contraceptive is in compliance with an April order from a U.S. District Court for the Eastern District of New York judge that compelled the agency to make emergency contraceptives available OTC without any age restrictions. The Department of Justice withdrew its appeal of Judge Edward Korman's order earlier this month, and FDA asked Teva to "promptly" submit an application with proposed labeling. FDA approved OTC sale of Plan B One-Step to those age 15 and over in May (see BioCentury Extra, June 11). ...