New Delhi: Drug firm Alembic Pharmaceuticals has received US health regulator’s nod for Amantadine Hydrochloride capsules used to treat symptoms of infection caused by influenza virus.
“The company has received approval from the United States Food and Drug Administration (USFDA) for its ANDA for Amantadine Hydrochloride capsules USP 100 mg,” Alembic Pharmaceuticals said in a BSE filing.
The approved Abbreviated New Drug Application (ANDA) is equivalent to Symmetrel capsules of Endo Pharmaceuticals.
Amantadine Hydrochloride capsules are used for the “treatment of signs and symptoms of infection caused by various strains of influenza A virus”, the company said.
The drug is also used in the treatment of parkinsonism and drug-induced extrapyramidal reactions, it added.
According to IMS December 2016 data, Amantadine Hydrochloride capsules had an estimated market size of USD 37 million.
The company now has a total of 58 ANDA approvals from the USFDA.