ForCast Orthopedics Gets QIDP Nod for Investigational Antibiotic
The FDA has granted a Qualified Infectious Disease Product (QIDP) designation to ForCast Orthopedics’ FC001 antibiotic candidate to treat patients with periprosthetic joint infection, a rare complication following joint replacement procedures.
FC001 is being developed as a targeted antibiotic therapy to be placed directly into the infected joints.
The QIDP designation offers sponsors a faster FDA review to incentivize development of new antifungal and antibacterial drugs that treat serious or life-threatening infections.
A drug that is designated as a QIDP and is then approved gets a 5-year extension of any exclusivity for which the application qualifies.
March 1, 2023
