Jubilant Life Sciences Ltd has received Abbreviated New Drug Application (ANDA) final approval for Amantadine Hydrochloride Tablets, 100 mg, the generic version of Symmetrel® of Endo, which is indicated for the prophylaxis and treatment of signs and symptoms of infection caused by various strains of influenza A virus. It is also indicated in the treatment of Parkinsonism and drug-induced extrapyramidal reactions.
This is the ninth approval that we have received from the USFDA during the current financial year. As on December 31, 2017, Jubilant had a total of 86 ANDAs for Oral Solids filed in the US, of which 56 had been approved and 12 Injectable filings, of which 10 had been approved.
