US FDA approves Amantadine Hydrochloride Tablets, 100 mg from Alembic Pharma

Alembic Pharmaceuticals has received approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Amantadine Hydrochloride Tablets, 100 mg. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Symmetrel Tablets, 100 mg, of Endo Pharmaceuticals.

They are indicated for the prophylaxis and treatment of signs and symptoms of infection caused by various strains of influenza A virus. These tablets· are also indicated in the treatment of Parkinsonism and drug-induced extrapyramidal reactions.

Amantadine Hydrochloride Tablets, 100 mg have an estimated market size of $13 million for twelve months ending June, 2020 according to IQVIA.

Alembic has a cumulative total of 132 ANDA approvals (114 final approvals and 18 tentative approvals) from USFDA.