Sun Pharma gets ANDA nod for sugammadex; two metformin labeling supplements approved
FDA approved Sun Pharma Industries' original ANDA for sugammadex sodium injection and cleared labeling supplements for two existing metformin hydrochloride ANDAs.
Sun Pharm Industries had three FDA approvals recorded this week, one new generic and two labeling updates on existing metformin products.
- Sun Pharm Inds Inc received original approval (ANDA214319) for sugammadex sodium solution for intravenous use, in strengths of 500MG base per 5ML and 200MG base per 2ML1, with a submission status date of 2026-07-28.
- Sun Pharm Industries received a labeling supplement approval (ANDA076038, SUPPL 34) covering metformin hydrochloride tablets in 850MG, 1GM, and 500MG strengths2, dated 2026-07-29.
- Sun Pharm Industries also received a labeling supplement approval (ANDA077124, SUPPL 10) for metformin hydrochloride extended release tablets, 500MG strength3, dated 2026-07-29.
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