American Pharmaceutical gets FDA approvals for ceftriaxone for injection

By E. Janene Geiss

Philadelphia, Feb. 16 - American Pharmaceutical Partners, Inc. said Thursday that it has received two approvals from the Food and Drug Administration for its abbreviated New Drug Applications for ceftriaxone for injection, with the FDA's clearance of the issues surrounding the raw material supplier for this product.

The company said it received approvals for five product codes for ceftriaxone, the generic equivalent of Roche Pharmaceuticals' Rocephin, including single dose and pharmacy bulk pack, according to a company news release.

According to IMS, ceftriaxone is the No. 1 third-generation cephalosporin in both dollar sales and units sold, officials said. Total annual sales in 2005 of ceftriaxone exceeded $570 million.

American Pharmaceutical said it will begin marketing immediately.

"Ceftriaxone is a crucial drug for our customers and one that physicians rely on to treat many serious infections," Patrick Soon-Shiong, chairman and chief executive officer, said in the release.

"With the approval of ceftriaxone, [American Pharmaceutical] retains its position with the largest portfolio of anti-infectives in the generic injectables industry and its leadership position in the cephalosporin market," he added.

American Pharmaceutical said it will supply ceftriaxone in 250 mg, 500 mg, 1 g and 2 g single-dose vials, as well as a 10 g pharmacy bulk pack.

The product is preservative-free and AP-rated, and each vial will include a bar code and latex-free vial stopper, officials said.

Ceftriaxone is a broad-spectrum anti-infective used to treat several types of bacterial infections, including lower respiratory tract infections, acute bacterial otitis media, skin and skin structure infections, urinary tract infections, uncomplicated gonorrhea, pelvic inflammatory disease, bacterial septicemia, bone and joint infections, intra-abdominal infections, meningitis and surgical prophylaxis.

American Pharmaceutical is a Schaumburg, Ill., specialty drug company that develops, manufactures and markets injectable pharmaceutical products, focusing on the oncology, anti-infective and critical care markets.

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