FDA Approves FLUVOXAMINE MALEATE EXTENDED-RELEASE — Zydus Pharmaceuticals USA Inc.

Zydus Pharmaceuticals USA Inc.’s approved ANDA for fluvoxamine maleate extended-release provides a generic alternative to the antidepressant market, effectively extending the launch window for revenue generation ahead of the 2031 expiration of the brand patent. This approval adds to the company’s growing portfolio of generic neurologic offerings and diversifies its product mix as patent expiration cliffs loom across major brands.