Biocraft cefadroxil ANDA approval

Executive Summary

Generic version of Bristol-Myers' Ultracef and Duracef 500 mg caps approved Feb. 10. In January, Biocraft had filed suit against Bristol-Myers seeking declaratory judgment invalidating Bristol's patent covering cefadroxil, which reportedly covers the crystalline form of the bulk material and expires in 2004. An ongoing hearing will determine whether Biocraft should be prohibited from marketing prior to a final decision, Biocraft said. The firm said it could start shipping the product before the end of March unless barred by a court order.