Alembic Pharmaceuticals gets USFDA nod for anti-viral drug

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Drug firm Alembic Pharmaceuticals on Friday said it has received approval from the US health regulator for Amantadine Hydrochloride tablets, used for treatment of influenza A virus.

The approved product is therapeutically equivalent to the reference listed drug product Symmetrel tablets of Endo Pharmaceuticals, Inc.

In a regulatory filing, Alembic Pharmaceuticals said "it has received approval from the US Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Amantadine Hydrochloride tablets in the strength of 100 mg”.

Amantadine Hydrochloride tablets are indicated for the prophylaxis and treatment of signs and symptoms of infection caused by various strains of influenza A virus.

Quoting IQVIA data, Alembic Pharma said, "Amantadine Hydrochloride Tablets, 100 mg have an estimated market size of USD 13 million for twelve months ending June, 2020."

IQVIA is an American multi-national company serving the combined industries of health information technology and clinical research.

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