Generic Pravachol approval
This article was originally published in The Tan Sheet
Executive Summary
FDA approves Barr Pharmaceuticals and subsidiary Pliva's generic version of Bristol-Meyers Squibb's cholesterol drug Pravachol Nov. 28. The Woodcliff Lake, N.J.-based company says it plans to launch 10 mg, 20 mg and 40 mg of the pravastatin product immediately. Barr also says Pliva received tentative approval for its pravastatin 80 mg and plans to launch it following the expiration of a competitor's 180-day generic drug exclusivity period. Watson announced in May its launch of a generic Pravachol following FDA approval of Teva's ANDA (1"The Tan Sheet" May 1, 2006, p. 12)...
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