American Pharmaceutical Partners gets FDA OK for carboplatin injection

By E. Janene Geiss

Philadelphia, Feb. 17 - American Pharmaceutical Partners, Inc. announced Friday that it has received approval from the Food and Drug Administration for its abbreviated New Drug Application for carboplatin injection (liquid form) in a 600 mg multi-dose vial.

Carboplatin is the generic equivalent of Bristol-Myers Squibb Co.'s Paraplatin, according to a company news release.

Combined sales of the 600 mg dosage form by all suppliers exceeded $18.5 million in 2005, according to IMS.

American said it expects to begin marketing the 600 mg vial soon.

"This approval is an important line extension to our portfolio of carboplatin products," Patrick Soon-Shiong, chairman, president and chief executive officer, said in the release.

"According to IMS, sales from all suppliers of the 600 mg multi-dose vials of carboplatin are increasing. The addition of this dosage form expands our strong and growing oncology portfolio and allows us to compete in a growing market with only two other suppliers of this particular presentation," he added.

American's carboplatin 600 mg is preservative-free and AP rated, and the product vials include a latex-free vial stopper, bar code and Tall Man Lettering label enhancements to help differentiate American's carboplatin from other commonly used platinum-based chemotherapies with the same name suffix, officials said.

American said it also offers carboplatin in 450 mg (liquid and lyophilized), 150 mg (lyophilized) and 50 mg (lyophilized) vials.

Carboplatin is indicated for the initial treatment of advanced ovarian carcinoma in combination with other established approved chemotherapeutic agents, as well as for the palliative treatment of patients with ovarian carcinoma recurrent after prior chemotherapy.

American 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.

© 2015 Prospect News.
All content on this website is protected by copyright law in the U.S. and elsewhere. For the use of the person downloading only.
Redistribution and copying are prohibited by law without written permission in advance from Prospect News.
Redistribution or copying includes e-mailing, printing multiple copies or any other form of reproduction.