Lannett's (LCI) Memantine Hydrochloride Tabs ANDA Approved by U.S. FDA
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Lannett Company, Inc. (NYSE: LCI) 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."
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