Akorn-Strides, LLC has announced the approval of an ANDA for Flumazenil Injection USP, 0.1 mg/mL, packaged in 5 mL and 10 mL Multiple Dose Vials. Akorn-Strides, LLC is a joint venture that was formed in 2005 by Akorn, Inc. and Strides Arcolab Limited. The primary mission for the joint venture is to develop liquid, lyophilized and dry powder formulations of generic injectable products targeting several therapeutic markets with a major focus on anti-infectives, analgesics and CNS medicines. Flumazenil Injection is indicated for the complete or partial reversal of the sedative effects of benzodiazepines. Recent IMS data estimates an annual market size of approximately $14 million. The current product portfolio of the joint venture, which is funded equally by Akorn and Strides Arcolab, was recently expanded and now includes 29 ANDA’s with a total of 53 SKU’s, or product line offerings. To date, the joint venture has filed for 18 ANDA’s and received 6 ANDA approvals. The joint venture expects to generate product revenues in 2008 based on this and future product approvals, as well as subsequent product launches. In a statement given by Arthur S. Przybyl, President and CEO of Akorn and Member Manager of Akorn-Strides, LLC, “We are excited to announce this ANDA product approval for Flumazenil Injection. The Joint Venture has now placed purchase orders for five Injectable ANDA products, one for Fosphenytoin Sodium, two for Ondansetron, one for Flumazenil and one for an expected ANDA approval in the near term. The joint venture expects to launch these products in 2008.”
