Healthcare Industry News: dry powder
News Release - March 19, 2008
Akorn-Strides, LLC Announces FDA Approval for Fosphenytoin Sodium Injection USP, 100 mg/2mL and 500 mg/10mL
BUFFALO GROVE, Ill.--(HSMN NewsFeed)--Akorn-Strides, LLC today announced the approval of an ANDA for Fosphenytoin Sodium Injection USP, 100 mg/2mL and 500 mg/10mL (equivalent to Phenytoin Sodium). 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.Fosphenytoin Sodium Injection is a prodrug of Phenytoin Sodium and is indicated in the short term use for the prevention and control of generalized seizures occurring during neurosurgery. Recent IMS data estimates an annual marketsize of approximately $54 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. 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 Fosphenytoin Sodium 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 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. A stride 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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Source: Akorn
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