Regulatory News, In Brief
Executive Summary
Emergency contraceptive goes before advisory panel: Laboratoire HRA Pharma's emergency contraceptive ulipristal acetate gets a review from FDA's Reproductive Health Drugs Advisory Committee June 17. The company gained European Commission marketing authorization for the drug under the brand name EllaOne on May 15, 2009 (1"The Pink Sheet" DAILY, May 26, 2009). It can be used up to five days after unprotected sex, longer than Teva Pharmaceuticals' Plan B (levonorgestrel). Earlier this year, HRA Pharma agreed to sell Geneva-based PregLem rights to commercialize the same active ingredient to treat uterine fibroids and other benign reproductive disorders in the U.S. and Canada (2"The Pink Sheet" DAILY, April 15, 2010)