GSK Bactroban Generics Petition Cites FDA Topical Bioequivalence Methods
Executive Summary
A citizen petition from GlaxoSmithKline seeking to block Bactroban Cream (mupirocin) generics revisits the question of whether generics of topical dermatologic drug products containing different forms of the active ingredient should be approved by FDA
You may also be interested in...
Topical Bioequivalence For Unlike Emulsions Should Be Tested In Vivo – FDA
Bioequivalence of topical dermatologic drugs in different emulsions that target the stratum corneum should be determined through in vivo testing, FDA said
Ranbaxy Generic Ceftin May Clear FDA After USP Monograph Revision
Ranbaxy expects an ANDA approval for its generic version of GlaxoSmithKline's Ceftin shortly after U.S. Pharmacopeia monograph revisions for cefuroxime axetil become effective on Sept. 30.
Part D Discount Liability Coming Into Focus: CMS Releases Drug Cost Data
Newly released Medicare Part D data sheds light on the sales hit that branded pharmaceutical manufacturers will face when the coverage gap discount program gets under way in 2011