MUMBAI and BALTIMORE — The Food and Drug Administration has approved Lupin’s generic of Namenda XR (memantine hydrochloride) extended-release capsules, the company announced Thursday. The drug is indicated to treat moderate to severe Alzheimer’s-related dementia.
Lupin’s generic will be available in 7-, 14-, 21- and 28-mg dosage strengths. The drug had U.S. sales of $1.22 billion for the 12 months ended June 2016, according to IMS Health data.