FDA opens docket FDA-2026-N-13038 on VOQUEZNA exclusivity dispute; second ANDA filer Saba Ilac seeks consolidation with BDR case

Phathom Pharmaceuticals said the FDA has established public docket FDA-2026-N-13038 to solicit comments on legal and regulatory questions concerning BDR Pharmaceuticals' ANDA for VOQUEZNA, and that second ANDA filer Saba Ilac plans to seek consolidation with the BDR case.

Detected & updated continuously · Source: Nebula