Lupin gets USFDA final approval to market generic Tamiflu

New Delhi: Drug firm Lupin said it has received final approval from the US health regulator to market its Oseltamivir Phosphate for oral suspension used for the treatment of acute influenza in America.

The company has received final approval to market its generic Oseltamivir Phosphate for oral suspension from the United States Food and Drug Administration (USFDA), Lupin said in a filing to BSE.

The company's product is a generic version of Hoffman-La Roche Inc's Tamiflu for oral suspension, 6 mg/mL, it added.

Lupin shall commence promoting the product shortly, it added.

As per IQVIA MAT October 2017 data, Oseltamivir Phosphate for oral suspension, 6 mg (base)/mL had annual sales of approximately USD 358 million in the US, Lupin said.

The product is "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, " it added.