BRIEF—Remdesivir lyophilized powder OKed in India for use in COVID-19 patients

UK-incorporated Mylan today announced that the Drug Controller General of India (DCGI) has approved its remdesivir 100mg/vial for restricted emergency use in India as part of the DCGI's accelerated approval process to address urgent, unmet needs amid the evolving coronavirus 2019 (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.

The drug will be launched under the brand name Desrem in India, and will be available to patients in July at a price of 4,800 rupees ($64.34), which is 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, which is due to merge with Pfizer’s Upjohn unit to create a generics giant, will manufacture remdesivir in India at its injectables facilities, which also make product for the USA and have been inspected by the US Food and Drug Administration for compliance with good manufacturing practices.