FDA Sets Regulatory Review Period for Rebiotix's Rebyota, Opens Patent Extension Comment Window
July 07, 2025
July 07, 2025
WASHINGTON, July 7 (TNSFR) -- The U.S. Department of Health and Human Services Food and Drug Administration has established the regulatory review period for Rebyota, a pioneering therapy from Rebiotix Inc. for the prevention of recurrent Clostridioides difficile infection in adults. This step is required for the consideration of a patent term extension which covers the biologic product.
The FDA determined that Rebyota's regulatory review period spanned 3,461 days to 3,095 days . . .
The FDA determined that Rebyota's regulatory review period spanned 3,461 days to 3,095 days . . .