Akorn-Strides, LLC Announces FDA Approvals for Dexamethasone Sodium ...

Tag : sodium
Akorn-Strides, LLC today announced the approval of two ANDAs forDexamethasone Sodium Phosphate Injection USP, 4 mg (base)/mL in1mL, 5 mL, and 30 mL vials, and Dexamethasone Sodium PhosphateInjection USP, 10 mg (base)/mL in 10 mL vials. Akorn-Strides, LLCis a Joint Venture that was formed in 2005 by Akorn, Inc. (NASDAQ:AKRX) and Strides Arcolab Limited (NSE: STAR)(BSE: 532531). Theprimary mission of the Joint Venture is to develop liquid,lyophilized and dry powder formulations of generic injectableproducts targeting several therapeutic markets with a major focuson anti-infectives, analgesics and CNS medicines.

Dexamethasone Sodium Phosphate Injection is indicated to treatvarious conditions such as endocrine disorders, arthritis, blooddisorders, dermatologic diseases, severe allergic reactions, eyediseases, certain cancers, gastrointestinal diseases andrespiratory diseases. Recent IMS data estimates an annual marketsize for Dexamethasone of approximately $28 million.

The current product portfolio of the Joint Venture, which is fundedequally by Akorn and Strides Arcolab, was recently expanded and nowincludes 29 ANDAs with a total of 53 SKU's, or product lineofferings. To date, the Joint Venture has filed for 18 ANDAs andreceived 11 ANDA approvals. The Joint Venture has generated productrevenue in the third quarter of 2008 from its initial productlaunch of Rifampin for Injection.

In a statement given by Arthur S. Przybyl, President and CEO ofAkorn and Member Manager of Akorn-Strides, LLC, "We are excited toannounce these two ANDA product approvals for Dexamethasone SodiumPhosphate Injection."

About Akorn, Inc.

Akorn, Inc. manufactures and markets sterile specialtypharmaceuticals. Akorn has manufacturing facilities located inDecatur, Illinois and Somerset, New Jersey and markets anddistributes an extensive line of hospital and ophthalmicpharmaceuticals. Additional information is available at theCompany's website at www.akorn.com.

About Strides Arcolab Limited

Strides, listed on the Bombay Stock Exchange Limited (532531) andNational Stock Exchange of India Limited (STAR), is one of India'slargest exporters of branded generic pharmaceutical products.Strides manufactures pharmaceutical formulations in various dosageforms, including capsules, tablets and liquid injectables and isone of the world's top five manufacturers of softgel capsules.Strides also has the only globally dedicated softgel facility forhormones. In addition, Strides undertakes contract research and themanufacturing of specialty chemicals for various multinationalcompanies. Strides has a major presence in various developingcountries such as Africa, Latin America and Asia as well as indeveloped markets such as the U.S., Canada and part of Europe.Strides is one of the largest Indian suppliers of institutionallyfunded aid projects and is an approved supplier to the Global DrugFacility, UNICEF, and MSF amongst others.

Strides has 14 manufacturing plants spread across the U.S., Brazil,Mexico, Italy, Poland, Singapore and India. This broadmanufacturing network facilitates partnering with globalorganizations ranging from UNICEF and WHO-Global Drug Facility toEuropean and American pharmaceutical multinationals, privatelabelers and distribution chains. Strides has product registrationsin over 37 countries around the world and has earned ISO 9001, ISO14001 and GMP accreditations including USFDA. Strides employsapproximately 1,700 people across the globe. Strides also has amarketing presence in over 50 countries.

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