Amneal clears five FDA supplements: REMS update on buprenorphine/naloxone leads weekAug 14Weekly roundup, 5 itemsAmneal Pharmaceuticals, LLCbuprenorphine
FDA clears five ANDA supplements for Teva and Actavis Labs generics, mostly labeling updatesAug 14Weekly roundup, 5 itemsTeva Pharmaceutical Industries Ltd
Sun Pharma logs eleven FDA labeling supplements and two REMS updates in one weekAug 14Weekly roundup, 11 itemsisotretinoinSun Pharmaceutical Industries
FDA clears four Zydus labeling supplements for generic diabetes and diuretic tabletsAug 11Weekly roundup, 4 itemsZydus Lifesciences
CSPC Ouyi gets FDA labeling approvals for metformin hydrochloride tablets and ER tabletsAug 11Weekly roundup, 2 itemsCSPC Pharmaceutical Groupmetformin
Mylan wins FDA approval for labeling supplement on metformin ER tabletsAug 11Regulatory decisionmetforminViatris Inc.
Glenmark posts two ANDA labeling supplement approvals for metformin, riluzoleAug 11Weekly roundup, 2 itemsGlenmark Pharmaceuticalsmetformin
Sun Pharma gets ANDA nod for sugammadex; two metformin labeling supplements approvedJul 29Weekly roundup, 3 itemsmetforminsugammadex
Amneal adds metformin labeling approval alongside bosentan updatesJul 23Weekly roundup, 2 itemsAmneal Pharmaceuticals, LLCbosentan
Zydus wins two new generic approvals, edaravone and fluvoxamine ER, plus metformin label updatesJul 23Weekly roundup, 3 itemsedaravonefluvoxamine
Zydus Pharms gets FDA approvals for selenious acid ANDA and two glyburide/metformin label updatesJun 30Weekly roundup, 2 itemsglyburidemetformin
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