FDA APPROVES LUPIN'S 10-GRAM CEFTRIAXONE VIALS

Lupin Pharmaceuticals announced that the FDA has granted final approval for its abbreviated new drug application (ANDA) for ceftriaxone injection in 10-gram vials. The drug is the generic equivalent of Roche's Rocephin, an antibiotic.

Lupin had launched the 250-mg, 500-mg, 1-gram and 2-gram strengths of ceftriaxone vials in 2005. This is the company's 15th ANDA approval.

Lupin has distribution agreements with Baxter Healthcare for the U.S. hospital market and with Henry Schein for physician offices.