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Bristol/Teva “Authorized” Generic Agreement Approved By FTC

Executive Summary

The Federal Trade Commission is giving its formal blessing to an "authorized" generic agreement between Bristol-Myers Squibb and Teva involving the first generic version of Paraplatin (carboplatin)

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Paraplatin pediatric exclusivity ends

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...

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