Akorn-Strides, LLC Announces FDA Approval for Pamidronate Disodium Injection, 3 mg/mL and 9 mg/mL

Posted AtMarketwatch.com

LAKE FOREST, Ill., Nov 03, 2008 (BUSINESS WIRE) -- Akorn-Strides, LLC today announced that the U.S. Food and Drug Administration has granted approval for an Abbreviated New Drug Application (ANDA) for Pamidronate Disodium Injection, 3 mg/mL and 9 mg/mL in 10 mL vials. Akorn-Strides, LLC is a Joint Venture that was formed in 2004 by Akorn, Inc. (AKRX: Akorn Inc News, chart, profile, more Last: 2.30-0.82-26.28% 4:00pm 11/05/2008 Delayed quote data Add to portfolio Analyst Create alert Insider Discuss Financials Sponsored by: AKRX 2.30, -0.82, -26.3%) and Strides Arcolab Limited (NSE: STAR) (BSE: 532531). 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.

Pamidronate Disodium Injection is indicated for the treatment of hypercalcemia associated with malignancy and Paget's disease. Recent IMS data estimates an annual market size for Pamidronate Disodium Injection of approximately $21 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 12 ANDA approvals. The Joint Venture generated its initial product revenues in the third quarter of 2008, from the launch of Rifampin for Injection.

In a statement given by Arthur S. Przybyl, President and CEO of Akorn and Member Manager of Akorn-Strides, LLC, "We are pleased to announce the ANDA approval for Pamidronate Disodium Injection."

November 06, 2008