Paraplatin pediatric exclusivity ends
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" May 31, 2004, p. 7). Generics from Bedford, Pharmachemie, American Pharmaceutical Partners and Mayne were approved; ANDAs from Gensia Sicor and Faulding are tentatively approved...