FDA Approvals For Dexamethasone Sodium Phosphate Injection USP, 4 Mg (Base)/mL And Dexamethasone Sodium Phosphate Injection USP, 10 Mg (Base)/mL

Main Category: MRSA / Drug Resistance
Also Included In: Pain / Anesthetics;  Neurology / Neuroscience;  Clinical Trials / Drug Trials
Article Date: 04 Sep 2008 - 4:00 PDT

email to a friend   printer friendly   view / write opinions   rate article

Akorn-Strides, LLC announced the approval of two ANDAs for Dexamethasone Sodium Phosphate Injection USP, 4 mg (base)/mL in 1mL, 5 mL, and 30 mL vials, and Dexamethasone Sodium Phosphate Injection USP, 10 mg (base)/mL in 10 mL vials. 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 of 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.

Dexamethasone Sodium Phosphate Injection is indicated to treat various conditions such as endocrine disorders, arthritis, blood disorders, dermatologic diseases, severe allergic reactions, eye diseases, certain cancers, gastrointestinal diseases and respiratory diseases. Recent IMS data estimates an annual market size for Dexamethasone of approximately $28 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 ANDAs with a total of 53 SKU's, or product line offerings. To date, the Joint Venture has filed for 18 ANDAs and received 11 ANDA approvals. The Joint Venture has generated product revenue in the third quarter of 2008 from its initial product 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 excited to announce these two ANDA product approvals for Dexamethasone Sodium Phosphate 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 pharmaceutical formulations in various dosage forms, including capsules, tablets and 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 suppliers 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.

Materials in this press release may contain information that includes or is based upon forward-looking statements within the meaning of the Securities Litigation Reform Act of 1995. Forward-looking statements give our expectations or forecasts of future events. You can identify these statements by the fact that they do not relate strictly to historical or current facts. They use words such as "anticipate," "estimate," "expect," "project," "intend," "plan," "believe," and other words and terms of similar meaning in connection with a discussion of future operating or financial performance. In particular, these include statements relating to future steps we may take, prospective products, future performance or results of current and anticipated products, sales efforts, expenses, the outcome of contingencies such as legal proceedings, and financial results.

Any or all of our forward-looking statements here or in other publications may turn out to be wrong. They can be affected by inaccurate assumptions or by known or unknown risks and uncertainties. Many such factors will be important in determining our actual future results. Consequently, no forward-looking statement can be guaranteed. Our actual results may vary materially, and there are not guarantees about the performance of our stock.

Any forward-looking statements represent our expectations or forecasts only as of the date they were made and should not be relied upon as representing our expectations or forecasts as of any subsequent date. We undertake no obligation to correct or update any forward-looking statements, whether as a result of new information, future events or otherwise, even if our expectations or forecasts change. You are advised, however, to consult any further disclosures we make on related subjects in our reports filed with the SEC. In particular, you should read the discussion in the section entitled "Cautionary Statement Regarding Forward-Looking Statements" in our most recent Annual Report on Form 10-K, as it may be updated in subsequent reports filed with the SEC. That discussion covers certain risks, uncertainties and possibly inaccurate assumptions that could cause our actual results to differ materially from expected and historical results. Other factors besides those listed there could also adversely affect our results.

Akorn, Inc.