Mylan: India Approves Remdesivir For Restricted Emergency Use In COVID-19 Patients

(RTTNews) - Mylan N.V. (MYL) announced Monday that the Drug Controller General of India or DCGI has approved its remdesivir 100 mg/vial for restricted emergency use in COVID-19 patients in India. 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.

Remdesivir is an investigational new drug developed by Gilead Sciences. US FDA has granted emergency use authorization of Remdesivir to treat hospitalized patients with severe COVID-19 in the U.S.

Mylan previously announced a global collaboration agreement with Gilead Sciences for the commercialization of remdesivir in 127 low- and middle-income countries, including India.

In India, Mylan will launch the drug under the brand name DESREM. It will be available to patients in July at a price of 4,800 Indian rupees, which is more than 80% below the price of the drug's branded version that is available to governments in the developed world.

Mylan said it will manufacture remdesivir in India at its injectables facilities, which also make product for the U.S. and have been inspected by the U.S. Food and Drug Administration or FDA for compliance with good manufacturing practices.

The company continues to work to expand emergency use access for patients in the 127 low- and middle-income countries where it is licensed by Gilead Sciences to do so.

The approval by DCGI in India represents the first for Mylan in these 127 markets.