Lannett Announces Approval And Launch Of Paroxetine Extended Release Tablets USP, 12.5 Mg, 25 Mg, 37.5 Mg

PHILADELPHIA, July 11, 2016 /PRNewswire/ -- Lannett Company, Inc. LCI today announced that it recently received approval from the U.S. Food and Drug Administration (FDA) of its Abbreviated New Drug Application (ANDA) for Paroxetine Extended Release Tablets USP, 12.5 mg, 25 mg and 37.5 mg, the therapeutic equivalent to the reference listed drug, Paxil CR Extended-Release Tablets USP, 12.5 mg, 25 mg and 37.5 mg, of Apotex Technologies. According to IMS, total U.S. sales in 2015 of Paroxetine Extended Release-Tablets USP, 12.5 mg, 25 mg and 37.5 mg, at Average Wholesale Price (AWP) were approximately $122 million. The company said it has begun shipping product to customers.

"Paroxetine Extended Release Tablets is the first major approval from our Kremers Urban (KU) subsidiary and comes just eight months after the acquisition was completed," said Arthur Bedrosian, chief executive officer of Lannett. "I want to acknowledge our KU drug development team for their efforts in bringing this very difficult-to-develop product to patients suffering from depression.

"With only one other generic competitor currently available on the market, Paroxetine Extended Release Tablets represents a substantial opportunity for Lannett. The launch of Paroxetine, combined with our recently completed debt refinancing and six other recent product approvals, strengthens and reinforces our positive outlook for the coming year. Our fiscal 2017, which began on July 1, 2016, is currently exceeding our expectations."

About Lannett Company, Inc.:
Lannett Company, founded in 1942, develops, manufactures, packages, markets and distributes generic pharmaceutical products for a wide range of medical indications. For more information, visit the company's website at www.lannett.com.  

This news release contains certain statements of a forward-looking nature relating to future events or future business performance. Any such statement, including, but not limited to, successfully commercializing Paroxetine Extended Release-Tablets USP, 12.5 mg, 25 mg and 37.5 mg, whether expressed or implied, is subject to market and other conditions, and subject to risks and uncertainties which can cause actual results to differ materially from those currently anticipated due to a number of factors which include, but are not limited to, the risk factors discussed in the Company's Form 10-K and other documents filed with the SEC from time to time, including the prospectus supplement related to the proposed offering to be filed with the SEC. These forward-looking statements represent the Company's judgment as of the date of this news release. The Company disclaims any intent or obligation to update these forward-looking statements.

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SOURCE Lannett Company, Inc.