The final approval by the US Food & Drug Administration (USFDA) is for the Abbreviated New Drug Application (ANDA) oseltamivir phosphate for oral suspension of strength 6 mg/ml, Alembic Pharmaceuticals said in a regulatory filing.
The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Tamiflu oral suspension, 6 mg/ml of Hoffmann-La Roche, Inc, it added.
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Oseltamivir Phosphate, an influenza neuraminidase inhibitor (NAI), is indicated for the treatment of acute, uncomplicated influenza A and B in patients aged two weeks and above who have been symptomatic for no more than 48 hours.
It is also indicated for the prophylaxis of influenza A and B in patients aged one year and older, the company added.
It is also indicated as a prophylaxis of influenza A and B in patients one year and older, it added.
Oseltamivir phosphate for oral suspension 6 mg/ml had an estimated market size of USD 27 million for 12 months ended March 2026, Alembic said citing IQVIA data.
