LAKE FOREST, Ill., Sept. 17, 2015 (GLOBE NEWSWIRE) -- Akorn, Inc. (Nasdaq:AKRX), a leading specialty pharmaceutical company, today announced that it has launched Promethazine Hydrochloride and Phenylephrine Hydrochloride Syrup (Promethazine/Phenylephrine) and Promethazine Hydrochloride, Phenylephrine Hydrochloride and Codeine Phosphate Syrup CV (Promethazine/Phenylephrine/Codeine). The launches follow approval of abbreviated new drug applications (ANDAs) for both products from the U.S. Food and Drug Administration (FDA) in December 2014.
The two products complement Akorn's existing Promethazine formulations which include Promethazine HCl Oral Solution, USP; Promethazine HCl and Codeine Phosphate Syrup CV; and Promethazine HCl and Dextromethorphan HCl Oral Solution.
About Promethazine/Phenylephrine Syrup
Akorn's Promethazine/Phenylephrine Syrup is indicated for the temporary relief of upper respiratory symptoms, including nasal congestion, associated with allergy or the common cold. Marketed under Akorn's Hi-Tech Pharmacal label, fruit-flavored Promethazine/Phenylephrine Syrup is available in a 473 mL bottle.
According to IMS Health, branded and generic sales of Promethazine/Phenylephrine Syrup were approximately $9 million for the twelve months ended July 31, 2015.
About Promethazine/Phenylephrine/Codeine Syrup
Akorn's Promethazine/Phenylephrine/Codeine Syrup is indicated for the temporary relief of coughs and upper respiratory symptoms, including nasal congestion, associated with allergy and the common cold. Also marketed under Akorn's Hi-Tech Pharmacal label, fruit-flavored Promethazine/Phenylephrine/Codeine Syrup is available in 118 mL and 473 mL bottles.
According to IMS Health, branded and generic sales of Promethazine/Phenylephrine/Codeine Syrup were approximately $16 million for the twelve months ended July 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 sterile and 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.
Executive Director, Investor Relations