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ANI Pharmaceuticals Announces FDA Approval of Memantine Hydrochloride Extended-Release Capsules
BAUDETTE, Minn., March 2, 2020 /PRNewswire/ -- ANI Pharmaceuticals, Inc. ("ANI") (Nasdaq: ANIP) today announced that it has received approval of the Company's
About this update from Ani Pharmaceuticals, Inc.
[{"type":"text","content":"BAUDETTE, Minn., March 2, 2020 /PRNewswire/ -- ANI Pharmaceuticals, Inc. (\"ANI\") (Nasdaq: ANIP) today announced that it has received approval of the Company's abbreviated new drug application (ANDA) from the U.S. Food and Drug Administration (FDA) for Memantine Hydrochloride Extended-Release Capsules 7 mg, 14 mg, 21 mg and 28 mg. The current annual U.S. market for this product is approximately $127 million, according to IQVIA.\nArthur S. Przybyl, ANI's President and CEO commented, \"This ANDA approval comes from the recently announced acquisition of 23 commercial and pipeline drugs and will be the third launch from the acquired pipeline. We plan to launch the drug in the near term.\"\nAbout Memantine Hydrochloride Extended-Release Capsules\nMemantine Hydrochloride Extended-Release Capsules are indicated for the treatment of moderate and severe dementia of the Alzheimer's type. For more information, including the complete list of indications and usages, please see the Full Prescribing Information.\nAbout ANI\nANI Pharmaceuticals, Inc. (the \"Company\" or \"ANI\") is an integrated specialty pharmaceutical company developing, manufacturing, and marketing branded and generic prescription pharmaceuticals. The Company's targeted areas of product development currently include narcotics, oncolytics (anti-cancers), hormones and steroids, and complex formulations involving extended release and combination products. For more information, please visit our website www.anipharmaceuticals.com.\nForward-Looking Statements \nTo the extent any statements made in this release deal with information that is not historical, these are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, statements about price increases, the Company's future operations, products, financial position, operating results and prospects, the Company's pipeline or potential markets therefor, and other statements that are not historical in nature, particularly those that utilize terminology such as \"anticipates,\" \"will,\" \"expects,\" \"plans,\" \"potential,\" \"future,\" \"believes,\" \"intends,\" \"continue,\" other words of similar meaning, derivations of such words and the use of future dates. \nUncertainties and risks may cause the Company's actual results to be materia...