Lupin receives USFDA’s nod for generic Tamiflu Capsules

10 Jan 2018 Evaluate

Lupin has received final approval for its Oseltamivir Phosphate Capsules USP, 30 mg (base), 45 mg (base), and 75 mg (base) from the United States Food and Drug Administration (USFDA) to market a generic version of Hoffman-La Roche, Inc.'s Tamiflu Capsules, 30 mg, 45 mg, and 75 mg.

Lupin's Oseltamivir Phosphate Capsules USP, 30 mg (base), 45 mg (base), and 75 mg (base) are the AB rated generic equivalent of Hoffman-La Roche, Inc.'s Tamiflu Capsules, 30 mg, 45 mg, and 75 mg. Oseltamivir Phosphate Capsules USP, 30 mg (base), 45 mg (base), and 75 mg (base) are indicated for the treatment of acute, uncomplicated influenza A and B in patients 2 weeks of age and older who have been symptomatic for no more than 48 hours, and prophylaxis of influenza A and B in patients 1 year and older.

Oseltamivir Phosphate Capsules USP, 30 mg, 45 mg, and 75 mg had annual sales of approximately $467.8 million in the US, as per IMS MAT October 2017.

Lupin is an innovation led transnational pharmaceutical company developing and delivering a wide range of branded & generic formulations, biotechnology products and APIs globally.


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