Mylan gets remdesivir approval for COVID-19 in India
July 9, 2020
By David Ho
HONG KONG – The Drug Controller General of India (DCGI) has approved Mylan NV’s remdesivir 100-mg vial for restricted emergency use in COVID-19 cases.
The drug received an accelerated approval for the treatment of COVID-19 in adults and children hospitalized with severe presentations of the disease. It will be released in India under the brand name Desrem, and be available to patients at a price of INR4,800 (US$64.34) this month.
Mylan claims its price for the India market is more than 80% less than the price at which the branded version of remdesivir will be available to governments in the developed world. Its remdesivir will be manufactured in India at its injectables facilities there.
Mylan is one of the six Indian pharma companies that have received nonexclusive licenses from Gilead Sciences Inc. to manufacture and distribute generic remdesivir in 127 low- and middle-income countries. The approval from the DCGI in India represents the first for Mylan in those 127 markets.