Lannett Receives FDA Approval For Memantine Hydrochloride Oral Solution, 2 mg/mL

PHILADELPHIA, Oct. 14, 2015 /PRNewswire/ -- Lannett Company, Inc. (NYSE: LCI) today announced that its wholly owned subsidiary, Silarx Pharmaceuticals, Inc., has received approval from the U.S. Food and Drug Administration (FDA) of its Abbreviated New Drug Application (ANDA) for Memantine Hydrochloride Oral Solution 2 mg/mL, the therapeutic equivalent to the reference listed drug Namenda® Oral Solution, 2 mg/mL of Forest Pharmaceuticals. According to IMS, for the year ended June 2015 total sales of Memantine Hydrochloride Oral Solution 2 mg/mL at Average Wholesale Price (AWP) were approximately $12 million

 

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"Memantine Hydrochloride Oral Solution 2 mg/mL is an important product used to treat dementia associated with Alzheimer's disease," said Arthur Bedrosian, chief executive officer of Lannett. "This product expands our portfolio of generic drugs in liquid dosage form and represents the second approval received from our recently completed acquisition of Silarx. We expect to commence marketing immediately."

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 Memantine Hydrochloride Oral Solution 2 mg/mL, 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.

Contact:

Robert Jaffe


Robert Jaffe Co., LLC


(424) 288-4098

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SOURCE Lannett Company, Inc.


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