Paraplatin Pediatric Exclusivity Ends
This article was originally published in The Pink Sheet Daily
Executive Summary
Multiple ANDAs for Bristol-Myers Squibb's Paraplatin (carboplatin) were approved Oct. 14, marking the end of pediatric exclusivity as well as Teva's sole-generic status. Teva has been distributing an "authorized" generic under a patent suit settlement (1"The Pink Sheet" DAILY, April 27, 2004). Generics from Bedford, Pharmachemie, American Pharmaceutical Partners and Mayne were approved; ANDAs from Gensia Sicor and Faulding are tentatively approved