Mylan secures DCGI approval for Remdesivir

Chennai: Mylan N V has announced that 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 hospitalised with severe presentations of the disease,” it said in a statement.

The drug will be launched under the brand name Desremtm in India and will be available to patients in July at a price of Rs 4,800, which is more than 80 per cent 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 world-class injectables facilities, which also make product for the US and have been inspected by the US Food and Drug Administration (FDA) for compliance with good manufacturing practices.

 

NT Bureau