Ranbaxy Generic Ceftin May Clear FDA After USP Monograph Revision
Executive Summary
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.
You may also be interested in...
GSK Bactroban Generics Petition Cites FDA Topical Bioequivalence Methods
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
GSK Bactroban Generics Petition Cites FDA Topical Bioequivalence Methods
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
USP Monograph Changes Could Be Strategy To Impede Generic Entry
Modifications to a branded drug's U.S. Pharmacopeia monograph could pose impediments to generic entry, Frommer, Lawrence & Haug attorney Andrew Berdon said