Jubilant Life Sciences Ltd has received abbreviated new drug application (ANDA) final approval from the US Food and Drug Administration (US FDA) for memantine hydrochloride tablets USP 5 mg and 10 mg, the generic version of Namenda of Forest Laboratories, which is used for treatment of moderate to severe dementia in patients with Alzheimer’s disease.
As on June 30, 2015, Jubilant Life Sciences had a total of 815 filings for formulations of which 389 have been approved in various regions globally. This includes 72 ANDAs filed in the US, of which 38 have been approved and 46 dossier filings in Europe.
As on June 30, 2015, Jubilant Life Sciences had a total of 815 filings for formulations of which 389 have been approved in various regions globally. This includes 72 ANDAs filed in the US, of which 38 have been approved and 46 dossier filings in Europe.