LAKE FOREST, Ill., Jan. 20, 2015 (GLOBE NEWSWIRE) -- Akorn, Inc. (Nasdaq:AKRX), today announced that it has received approval from the U.S. Food and Drug Administration (FDA) on the Company’s New Drug Application (NDA) for Phenylephrine Hydrochloride Ophthalmic Solution, USP, 2.5% and 10%. Akorn intends to re-launch the product shortly.
Akorn’s Chief Executive Officer Raj Rai stated, “Phenylephrine represents our first product approval of 2015 and builds on our 14 product approvals in 2014. While IMS Health estimates ophthalmic phenylephrine sales to be approximately $8 million for the three months ending November 30, 2014, we at Akorn believe the market size is significantly larger given that most ophthalmic phenylephrine products are shipped directly to physician and optometrist offices.”
“We are excited to bring our non-refrigerated phenylephrine product back to the market shortly and we expect a number of additional FDA approvals and product launches as we continue to progress through 2015,” said Rai.
About Phenylephrine Hydrochloride Ophthalmic Solution, USP, 2.5% and 10%
Akorn’s Phenylephrine Hydrochloride Ophthalmic Solution, USP, is an alpha-1 adrenergic receptor agonist indicated to dilate the pupil. Phenylephrine is commonly used by optometrists, ophthalmologists and other physicians to dilate patients’ pupils before ocular examinations. Akorn’s approval represents the second NDA approval for an ophthalmic phenylephrine product following the approval of a competing NDA product in 2013 and the subsequent withdrawal of grandfathered products from the market in 2014.
Following this approval, Akorn’s product will compete against the one other approved NDA product. However, Akorn’s product does not require refrigeration, providing greater optometrist and physician convenience compared to the competing phenylephrine product.
Akorn’s Phenylephrine Hydrochloride Ophthalmic Solution, USP 2.5% will be available in 2mL and 15mL fill sizes and Phenylephrine Hydrochloride Ophthalmic Solution, USP 10% will be available as a 5mL fill size.
About Akorn, Inc.
Akorn, Inc. (“Akorn” or the “Company”) 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.
CONTACT: Investors/Media: Dewey Steadman Executive Director, Investor Relations (847) 582-6923 investor.relations@akorn.com
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