New Delhi: Alembic Pharmaceuticals Ltd on Friday said it has received final approval from the US health regulator for its generic version of oseltamivir phosphate for oral suspension indicated for treatment of influenza.
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.
