FDA grants tentative approval for Sagent Pharmaceuticals' adenosine injection

Apr 23 2010

Sagent Pharmaceuticals, Inc., a privately held specialty pharmaceutical company, today announced that the U.S. Food and Drug Administration had granted tentative approval of adenosine injection, USP, the generic equivalent of Astellas Pharmaceuticals' Adenoscan®, in 60 mg per 20 mL and 90 mg per 30 mL vials.  IMS data indicate that the 2009 U.S. innovator market for these adenosine presentations approximated $124 million.  The Company plans to launch the product upon expiry of applicable innovator patents.

Upon approval, adenosine will be launched under 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.