Alembic receives FDA nod for generic Symmetrel
The Food and Drug Administration has given its blessing for Alembic’s amantadine hydrochloride tablets.
The product, indicated for the prophylaxis and treatment of signs and symptoms of infection caused by various strains of influenza A virus, as well as parkinsonism and drug-induced extrapyramidal reactions, was approved in 100-mg dosage strength.
The product is the generic of Endo’s Symmetrel tablets.
Amantadine hydrochloride tablets have a market value of roughly $13 million for the 12 months ended June 2020 according to IQVIA.