Alembic Pharmaceuticals today announced that the company has received approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Amantadine Hydrochloride Capsules, USP, 100mg.

The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD) Symmetrel Capsules, 100mg, of Endo Pharmaceuticals Inc. Amantadine Hydrochloride Capsules, USP are indicated for the prophylaxis and treatment of signs and symptoms of infection caused by various strains of influenza A virus. Amantadine Hydrochloride Capsules, USP are also indicated in the treatment of parkinsonism and drug-induced extrapyramidal reactions.

Amantadine Hydrochloride Capsules have an estimated market size of USD 37 million for twelve months ending December 2016 according to IMS.

Alembic now has a total of 58 ANDA approvals (52 final approvals and 6 tentative approvals) from USFDA.

Shares of the company gained Rs 8.15, or 1.53%, to trade at Rs 540.05. The total volume of shares traded was 1,450 at the BSE (9.55 a.m., Thursday).