Lannett Announces Approval For Memantine Hydrochloride Tablets USP, 5 mg And 10 mg
PHILADELPHIA, Nov. 14, 2016 /PRNewswire/ -- Lannett Company, Inc. (NYSE: LCI) today announced that it received approval from the U.S. Food and Drug Administration (FDA) of its Abbreviated New Drug Application (ANDA) for Memantine Hydrochloride Tablets USP, 5 mg and 10 mg, the therapeutic equivalent to the reference listed drug, Namenda Tablets, 5 mg and 10 mg, of Forest Laboratories LLC. According to IMS, total U.S. sales in 2015 of Memantine Hydrochloride Tablets USP, 5 mg and 10 mg, at Average Wholesale Price (AWP) were approximately $50 million.
"Memantine Hydrochloride Tablets is indicated for the treatment of moderate to severe dementia," said Arthur Bedrosian, chief executive officer of Lannett. "This product is in addition to our Memantine Oral Solution and represents the ninth product approval we have received in calendar 2016. We expect to commence marketing the product in approximately two months."
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 Tablets USP, 5 mg and 10 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.