Posted by Michael Wonder on 25 Mar 2017
Symbiomix Therapeutics announces FDA’s acceptance of new drug application for Solosec with priority review status
23 March 2017 - Symbiomix today announced that the US FDA has accepted for filing the Company’s new drug application for its lead investigational product candidate Solosec (secnidazole oral granules), an innovative antibiotic designed to treat bacterial vaginosis.
In accordance with the FDA’s priority 6-month review designation, the agency has established a user-fee goal date under the Prescription Drug User Fee Act of 17 September 2017. Symbiomix submitted the new drug application in January 2017.
