Strides Arcolab receives US FDA approval for Bacitracin
12 May 2010
Strides Arcolab Limited (Strides) said today that the US Food and Drug Administration has approved Bacitracin injectible, an anti-infective product used to treat pneumonia and empyema, the company said in a statement.
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.
The total 2009 U.S. market for injectable Bacitracin is around $32 million, according to IMS data. Launch is expected in the third quarter of 2010.
The company said, Bacitracin will be launched under the partnership between Strides and Sagent Pharmaceuticals. Strides develops and supplys more than 25 injectable products for the U.S. market which will be marketed by Sagent.
In March, Strides Arcolab acquired SA firm Aspen's stake in two cancer drug making joint ventures, Onco Therapies in India and Onco Laboratories in Cyprus, for $117 million, allowing it to license existing and future oncology products to Aspen Pharmacare. (See ''Strides Arcolab acquires SA firm Aspen's stake in two joint ventures.)