Granting additional market exclusivity to the drug Ansaid: hearing before the Subcommittee on Health and the Environment of the Committee on Energy and Commerce, House of Representatives, One Hundred Second Congress, second session, February 20, 1992, Volume 4
United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Health and the Environment
U.S. Government Printing Office, 1992 - Law - 66 pages
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26 months 79 months active ingredient adverse event agency ALEX McMILLAN Allergan ANDA moratorium period Ansaid application approval date approval of Ansaid approval process approved before Ocufen approved drug April Arthritis Advisory Committee benoxaprofen bioequivalence bone Boots Chairman Chemical Entity Chemical Entity NCE Competition and Patent Congress December delay Dingell Dophen DPC-PTRA enactment Drug Application drug approval Drug Price Competition Engelberg factors FDA officials FDA review February February 19 Feldene files NDA flurbiprofen tablets fracture GPIA granted Harter Health ibuprofen Intergovernmental Relations Subcommittee legislation manufacturer months of patent months review Motrin NCE drug NCE exclusivity NDA's non-patent exclusivity Non-steroidal anti-inflammatory drugs Nuprin Ocufen Oraflex osteoporosis patent extension patent term extension Patent Term Restoration period of market pharmaceutical priority PTRA questions regulatory review reports respond result safety and efficacy Scenario sponsor Suprol Term Restoration Act THEODORE COOPER therapeutic gain Upjohn filed Upjohn product Waxman Zomax