Lupin receives tentative FDA approval for Namenda tablets

Lupin announced this week that its memantine hydrochloride tablets, which are to be marketed under the name Namenda, have received tentative approval from the Food and Drug Administration (FDA).

The abbreviated new drug application encompassed 5mg and 10mg doses and the therapy is indicated for the treatment of moderate-to-severe dementia of the Alzheimer’s variety.

“We are pleased to receive this tentative approval and look forward to bringing Memantine HCl tablets to the […] market as an affordable generic alternative post-patent expiry,” explained Vinita Gupta, group president and chief executive officer of Lupin Pharmaceuticals.

This news comes after Lupin and Forest Laboratories settled a dispute that arose between the two firms regarding these tablets, which they jointly developed.

In adherence with the original settlement, Lupin will be licensed under the relevant patents and is free to commercially launch its generic product, it was ruled last month.