LAKE FOREST, Ill., July 8, 2015 (GLOBE NEWSWIRE) -- Akorn, Inc. (Nasdaq:AKRX), a leading specialty pharmaceutical company, today announced that it has launched Acetylcysteine Injection 6 g/30 mL in 30 mL single-dose vials. The launch follows an approval of an abbreviated new drug application (ANDA) for the product from the U.S. Food and Drug Administration (FDA) on March 24, 2015. Akorn's product is therapeutically equivalent to Acetadote® injection marketed by Cumberland Pharmaceuticals Inc.
About Acetylcysteine Injection
Akorn's Acetylcysteine Injection is an intravenous antidote for the treatment of acetaminophen overdose. Akorn's product is available in a 6 g/30 mL (200 mg/mL) concentration in 30 mL single-dose vials. According to IMS Health, branded and generic sales of Acetylcysteine Injection were approximately $29 million for the twelve months ended May 31, 2015.
Akorn, Inc. is a specialty pharmaceutical company engaged in the development, manufacture and marketing of multisource and branded pharmaceuticals. Akorn has manufacturing facilities located in Decatur, Illinois; Somerset, New Jersey; Amityville, New York; Hettlingen, Switzerland and Paonta Sahib, India where the Company manufactures ophthalmic, injectable and specialty non-sterile pharmaceuticals. Additional information is available on the Company's website at www.akorn.com.
Forward Looking Statements
This press release includes statements that may constitute "forward looking statements", including projections of sales and other statements regarding Akorn's launches, regulatory approvals, goals and strategy. These statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Because such statements inherently involve risks and uncertainties, actual future results may differ materially from those expressed or implied by such forward-looking statements. You can identify these statements by the fact that they do not relate strictly to historical or current facts. Factors that could cause or contribute to such differences include, but are not limited to: the difficulty of predicting the timing or outcome of product development efforts, including FDA and other regulatory agency approvals and actions, if any; the impact of competitive products and pricing; the timing and success of product launches; difficulties or delays in manufacturing; the availability and pricing of third party sourced products and materials; successful compliance with FDA and other governmental regulations; changes in the laws and regulations and such other risks and uncertainties outlined in Akorn's periodic public filings with the Securities and Exchange Commission and in other written or oral investor communications. Other factors besides those listed there could also adversely affect our results. Except as expressly required by law, Akorn disclaims any intent or obligation to update these forward-looking statements.
The addressable IMS market size figures presented in this press release outline the approximate aggregate size of the potential market and are not forecasts of our future sales.
Acetadote® is a registered trademark of Cumberland Pharmaceuticals Inc.
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