Alembic Pharma gets USFDA approval for Oseltamivir Phosphate Capsules USP

MUMBAI, June 25:Major Pharma Alembic Pharmaceuticals Limited on Tuesday said it has received approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Oseltamivir Phosphate Capsules USP, 30 mg (base), 45 mg (base) and 75 mg (base).
The approved ANDA is therapeutically equivalent to the reference listed drug (RLD), Tamiflu Capsules, 30 mg (base), 45 mg (base) and 75 mg (base), of Hoffman-La Roche, Inc.
Oseltamivir Phosphate Capsules USP are indicated for the treatment of acute, uncomplicated illness due to influenza A and B infection in patients 2 weeks of age and older who have been symptomatic for no more than 48 hours. It is also indicated for the prophylaxis of influenza A and B in patients 1 year and older.
Oseltamivir Phosphate Capsules has an estimated market size of US$ 647 million for twelve months ending December 2018 according to IQVIA.
Alembic now has a total of 97 ANDA approvals (85 final approvals and 12 tentative approvals) from USFDA.