Posted by Michael Wonder on 03 Aug 2020
Sonoran Biosciences announces qualified infectious disease product designation granted by FDA for SBG003 for surgical site infections in abdominal surgery
3 August 2020 - QIDP designation allows for FDA priority review, fast-track designation and an additional five years of market exclusivity for SBG003.
Sonoran Biosciences announced today that the Company’s lead product SBG003 (tobramycin and vancomycin hydrogel) has been granted qualified infectious disease product designation by the U.S. FDA for prevention of post-abdominal surgical site infection.
Sonoran plans to initially evaluate SBG003 in colorectal surgery, a subset of abdominal surgery that is associated with the highest incidence of surgical site infection among elective operations.
