Akorn-Strides, LLC Announces FDA Approval For Tobramycin Injection USP, 80 Mg/2mL And 1.2 Grams/30mL

Main Category: Infectious Diseases / Bacteria / Viruses
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 13 Mar 2008 - 2:00 PDT

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Akorn-Strides, LLC announced the approval of an ANDA for Tobramycin Injection USP, 80 mg/2mL and 1.2 grams/30mL. Akorn-Strides, LLC is a Joint Venture that was formed in 2005 by Akorn, Inc. (NASDAQ: AKRX) and Strides Arcolab Limited (NSE: STAR, BSE: 532531). The primary mission for the Joint Venture is developing liquid, lyophilized and dry powder fill generic injectable products targeting several therapeutic markets with a major focus on anti-infectives, analgesics and CNS medicines.

Tobramycin Injection is an antibiotic and is indicated for the use in treating or preventing infections that are proven or strongly suspected to be caused by susceptible bacteria. Recent IMS data estimates an annual marketsize of approximately $19 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 17 ANDA's. 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 product approval for Tobramycin Injection."

About Akorn, Inc.

Akorn, Inc. manufactures and markets sterile specialty pharmaceuticals. Akorn has manufacturing facilities located in Decatur, Illinois and Somerset, New Jersey and markets and distributes an extensive line of hospital and ophthalmic pharmaceuticals. Additional information is available at the Company's website at http://www.akorn.com.

About Strides Arcolab Limited

Strides, listed on the Bombay Stock Exchange Limited (532531) and National Stock Exchange of India Limited (STAR), is one of India's largest exporters of branded generic pharmaceutical products. Strides manufactures pharmaceuticals formulations in various dosage forms, including capsules, tablets, liquid injectables and is one of the world's top five manufacturers of softgel capsules. Strides also has the only globally dedicated softgel facility for hormones. In addition, Strides undertakes contract research and the manufacturing of specialty chemicals for various multinational companies. Strides has a major presence in various developing countries such as Africa, Latin America and Asia as well as in developed markets such as the U.S., Canada and part of Europe. Strides is one of the largest Indian supplier of institutionally funded aid projects and is an approved supplier to the Global Drug Facility, UNICEF, and MSF amongst others.

Strides has 14 manufacturing plants spread across the U.S., Brazil, Mexico, Italy, Poland, Singapore and India. This broad manufacturing network facilitates partnering with global organizations ranging from UNICEF and WHO-Global Drug Facility to European and American pharmaceutical multinationals, private labelers and distribution chains. Strides has product registrations in over 37 countries around the world and has earned ISO 9001, ISO 14001 and GMP accreditations including USFDA. Strides employs approximately 1,700 people across the globe. Strides also has a marketing presence in over 50 countries.

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http://www.akorn.com