FDA approves Sagent's bacitracin for pneumonia and empyema

Sagent Pharmaceuticals, Inc., a privately held specialty pharmaceutical company, today announced FDA approval of bacitracin for injection, USP (bacitracin), an anti-infective product used to treat pneumonia and empyema. Bacitracin will be offered in a 50,000 MU, AP-rated, preservative-free, latex-free, single-dose vial packaged both individually and in packages of ten.  These vials will feature Sagent's proprietary PreventIV Measures™ labeling and packaging, with distinctive labeling designs and easy to read drug name and dosage information. The total 2009 U.S. market for injectable bacitracin approximated $32 million, according to IMS data. Sagent expects to launch bacitracin in the third quarter of 2010.  

"Sagent is well positioned to meet the needs of the growing hospital anti-infective market. Including bacitracin, our anti-infective product line now encompasses nine products," said Jeffrey M. Yordon, Sagent's chief executive officer, founder, and chairman of the board. "To provide pharmacies of all types with the flexibility they require to stock bacitracin appropriate to their individual needs, Sagent will offer the product in both single units and in convenient packs of ten."

Bacitracin marks the seventh product approved from Sagent's partnership with Strides Arcolab.  Under this venture, Sagent and Strides Arcolab are jointly developing, supplying and marketing more than 25 injectable products for the U.S. market.  Strides is responsible for developing and manufacturing injectable products that Sagent will market in the United States.