ANI gets FDA nod for memantine hydrochloride

Patients with moderate and severe dementia associated with Alzheimer's will shortly have access to ANI’s memantine hydrochloride extended-release capsules. The FDA has approved the medication in dosage strengths of 7 mg, 14 mg, 21 mg, and 28 mg. 

Memantine hydrochloride ER capsules have a market value of 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," said Arthur Przybyl, ANI's president and CEO.