Natco gets CDSCO nod for emergency use of Baricitinib tablets for Covid-19 treatment
Unichem Labs gets FDA nod for new drug
Drug major Natco Pharma on Monday said it has received emergency use approval for Baricitinib tablets, for the treatment of COVID-19 positive patients, from the Central Drugs Standard Control Organization (CDSCO) in India.
CDSCO is responsible for approval of drugs, conduct of clinical trials, laying down the standards for drugs, control over the quality of imported drugs in the country and coordination of the activities of state drug control organisations.
'Natco Pharma Ltd has received emergency use approval for Baricitinib tablets, 1mg, 2mg and 4mg strengths from Central Drugs Standard Control Organization (CDSCO) in India,' the company said in a regulatory filing. Baricitinib in combination with Remdesivir, is used for treatment of COVID-19 positive patients, the company said.
Natco said it will request a compulsory license based on emergency use and in light of the grave and serious public health emergency across India due to the pandemic.
The company is ready to launch the product this week, so as to make the product available to suffering patients across India, it added.
