Alembic Pharma gets USFDA nod for generic version of Tamiflu capsules
The approved product, Oseltamivir Phosphate capsule is therapeutically equivalent to the reference listed drug (RLD), Tamiflu Capsules of Hoffman-La Roche, Inc.
New Delhi: Drug firm Alembic Pharmaceuticals Tuesday said it has received approval from the US health regulator for Oseltamivir Phosphate capsules, used for the treatment of influenza infection.
The approved product is therapeutically equivalent to the reference listed drug (RLD), Tamiflu Capsules of Hoffman-La Roche, Inc.
The approval from the United States Food and Drug Administration (USFDA) is for the company's abbreviated new drug application (ANDA) for Oseltamivir Phosphate Capsules USP in the strengths 30 mg, 45 mg and 75 mg, Alembic Pharmaceuticals said in a filing to BSE.
Quoting IQVIA data, Alembic Pharma said Oseltamivir Phosphate capsules has an estimated market size of USD 647 million for 12 months ending December 2018.
The company currently has a total of 97 ANDA approvals (85 final approvals and 12 tentative approvals) from USFDA, it added.