Phathom responds to BDR lawsuit challenging FDA's VOQUEZNA exclusivity decision

Phathom Pharmaceuticals said it is evaluating litigation filed by BDR Pharmaceuticals International against the FDA in U.S. District Court for the District of Columbia. BDR alleges the FDA improperly applied the GAIN Act to extend Phathom's NCE exclusivity for VOQUEZNA tablets; Phathom maintains the FDA correctly recognized 10 years of NCE exclusivity through May 3, 2032.

Detected & updated continuously · Source: Nebula