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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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Combo PPI/NSAID Products May Escape Outcomes Studies Despite Split FDA Panel Vote

Gastrointestinal Drugs Advisory Committee says endoscopically diagnosed ulcers are an appropriate surrogate endpoint for assessing the ability of gastroprotective agents to reduce NSAID-related GI toxicity but not for evaluating the comparative GI safety of NSAIDS.

PPI/NSAID Combinations Could Have Smoother Route To Approval After Review Division Harmonization

FDA will ask its Gastrointestinal Drugs Advisory Committee at a Nov. 4 meeting whether it agrees that endoscopically diagnosed ulcers are an appropriate surrogate endpoint, which would make large, pre-approval GI outcomes studies unnecessary.

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)

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