First-time generic approvals, September 2007

First-time generic approvals: fosphenytoin for injection; pantoprazole delayed-release tablets; cefotetan for injection; cefepime for injection.

Key Points

Fosphenytoin for injection, eq 50 mg/mL phenytoin (equiv to Cerebyx for injection)

ABRAXIS, APOTEX, BAXTER, BEDFORD, HOSPIRA, PHARMAFORCE, TEVA, WOCKHARDT

Pantoprazole delayed-release tablets, eq 20-and 40-mg base (equiv to Protonix delayed-release tablets)

Cefotetan for injection (equiv to Cefotan [discontinued])

ABRAXIS

Cefepime for injection, 500 mg/ vial, 1 g/vial, and 2 g/vial (equiv to Maxipime for injection)

ORCHID