FDA Plan To Harmonize Advice On NSAID GI Injury Assessments Draws Cmte. Rebuff
Executive Summary
FDA’s bid to harmonize two review divisions’ regulatory approaches to assessing and preventing gastrointestinal toxicity caused by non-steroidal anti-inflammatory drugs has been thrown a curve by the agency’s outside experts.
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PPI/NSAID Combinations Could Have Smoother Route To Approval After Review Division Harmonization
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Regulatory News, In Brief
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)