ANI Announces FDA Approval of Memantine Hydrochloride Extended-Release Capsules

ANI Pharmaceuticals 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.

"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," Arthur S. Przybyl, ANI's President and CEO said.

Memantine 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.

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