Lupin receives final approval for Oseltamivir Phosphate for Oral Suspension

From USFDA

Lupin announced that it has received final approval for its Oseltamivir Phosphate for Oral Suspension from the United States Food and Drug Administration (FDA) to market the generic version of Hoffman-La Roche, Inc.'s Tamiflu for Oral Suspension, 6 mg/mL. Lupin shall commence promoting the product shortly.

Lupin's Oseltamivir Phosphate for Oral Suspension, 6 mg (base)/mL is AB rated generic equivalent of Hoffman- La Roche, Inc's Tamiflu for Oral Suspension, 6 mg (base)/mL. Oseltamivir Phosphate for Oral Suspension, 6 mg (base)/mL is indicated for i) 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 ii) prophylaxis of influenza A and B in patients 1 year and older.

Oseltamivir Phosphate for Oral Suspension, 6 mg (base)/mL had annual sales of approximately USD 358 million in the US (IQVIA MAT October 2017).

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