Lupin gets FDA approval for generic Tamiflu
Lupin will be able to market its Oseltamivir Phosphate for oral suspension now
Pharma major Lupin today announced that it has received final approval for its generic Tamiflu tablet, used for treatment of acute and uncomplicated influenza, from the United States Food and Drug Administration (FDA).
Lupin will be able to market its Oseltamivir Phosphate for oral suspension now.
The drug is used 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, a company statement said.
Oseltamivir Phosphate for Oral Suspension had annual sales of approximately $358 million in the US (IQVIA MAT October 2017).
The company is a significant player in the cardiovascular, diabetology, asthma, paediatric, CNS, GI, anti-infective and NSAID space and holds the global leadership position in the anti-TB segment.
Lupin is the 11th largest generics pharmaceutical company by market capitalisation (December 31, 2017, Bloomberg).
For the financial year ended March 31, 2017, Lupin’s consolidated sales and net profit stood at Rs 171,198 million ($2.55 billion) and Rs 25,575 million ($381 million), respectively.
However, Lupin shares were trading slightly lower during the afternoon session.