Zydus wins two new generic approvals, edaravone and fluvoxamine ER, plus metformin label updates
FDA approved Zydus Pharms' generic edaravone injection and fluvoxamine maleate extended-release capsules, and cleared two labeling supplements for its metformin hydrochloride tablets.
Zydus had a busy week of FDA generic drug clearances, with two new ANDA approvals and two labeling updates to an existing product.
- FDA approved ANDA218349 for edaravone, an intravenous solution at 30MG/100ML (0.3MG/ML) strength, sponsored by Zydus Pharms, as an original ANDA 1 approval dated 2026-07-22.1
- FDA approved ANDA220447 for fluvoxamine maleate extended-release capsules, in 100MG and 150MG strengths, sponsored by Zydus Pharms, as an original ANDA 1 approval dated 2026-07-21.2
- FDA approved a labeling supplement (SUPPL 28) for ANDA077064, covering metformin hydrochloride tablets in 500MG, 850MG and 1GM strengths, sponsored by Zydus Pharms USA, dated 2026-07-23.3
- FDA approved a second labeling supplement (SUPPL 29) for the same ANDA077064 metformin hydrochloride tablets, also dated 2026-07-23.4
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