Mylan has secured regulatory approval for remdesivir in India for Restricted Emergency Use in COVID-19 patients.
The Drug Controller General of India (DCGI) has approved its remdesivir 100 mg/vial for restricted emergency use in India as part of the DCGI’s accelerated approval process to address urgent, unmet needs amid the COVID-19 pandemic.
The drug is approved for the treatment of suspected or laboratory confirmed incidences of COVID-19 in adults and children hospitalized with severe presentations of the disease.
It will be launched under the brand name DESREM in India, and will be available to patients in July at a price of INR 4,800 – more than 80% less than the price at which the branded version of this product will be available to governments in the developed world.
Mylan will manufacture remdesivir in India at its injectables facilities.