BackLupin gets USFDA nod to market generic Tamiflu
Lupin has received a final approval to market its generic Oseltamivir Phosphate for oral suspension, used in influenza treatment, from USFDA, the company said
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New Delhi: Drug firm Lupin on Wednesday 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 $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 on Wednesday trading at Rs813.50 per scrip in the afternoon trade on BSE, down 0.28% from its previous close.
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