![FDA, FTC and DOJ Enforcement of Medical Device Regulations FDA, FTC and DOJ Enforcement of Medical Device Regulations](https://www.fdanews.com/ext/resources/Book-Covers-2/BFFDEMDR-COVER.png?height=200&t=1685733565&width=200)
Home » India’s Dr. Reddy Denied Full Approval for Remdesivir
India’s Dr. Reddy Denied Full Approval for Remdesivir
![Remdesivir - drug](https://www.fdanews.com/ext/resources/test/Drug-Images4/Remdesivir-drug.gif?t=1594407914&width=430)
An expert panel of India’s drug regulatory authority has recommended against granting a request by Dr. Reddy’s Laboratories for a full approval of the COVID-19 antiviral remdesivir in that country.
India’s Central Drugs Standard Control Organization said it will keep the drug’s status as “restricted emergency use.” The decision follows a study by the World Health Organization, which found no clinical benefit or improvement in survival outcomes for COVID-19 patients in a review of multiple remdesivir trials.
Dr. Reddy’s is one of seven companies that Gilead Sciences granted nonexclusive, royalty-free licenses to to produce remdesivir during the pandemic.
In contrast to India’s health regulator, the FDA granted remdesivir full approval in October as a treatment for the coronavirus.
Upcoming Events
-
21Oct