Lupin gets USFDA's final nod to market generic Tamiflu

Drug firm Lupin today said it has received final nod from the US health regulator to market its Oseltamivir Phosphate for oral suspension used for 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.

Shares of Lupin were today trading at Rs 813.50 per scrip in the afternoon trade on BSE, down 0.28 per cent from its previous close.

(Only the headline and picture of this report may have been reworked by the Business Standard staff; the rest of the content is auto-generated from a syndicated feed.)

Business Standard is now on Telegram.
For insightful reports and views on business, markets, politics and other issues, subscribe to our official Telegram channel