FDA approves labeling supplement for Mylan's Amnesteem (isotretinoin)Sep 15Regulatory decisionisotretinoinViatris Inc.
Viatris: Ocuphire trial results posted, Amnesteem label update, gabapentin abuse study completedAug 21Weekly roundup, 3 itemsalprazolamgabapentin
Zydus Pharms gets two ANDA actions: isotretinoin label supplement, ascorbic acid injection approvalAug 21Weekly roundup, 2 itemsascorbic acidisotretinoin
Amneal's generic isotretinoin gets labeling supplement approved by FDAAug 21Regulatory decisionAmneal Pharmaceuticals, LLCisotretinoin
Teva gets FDA approval for generic tofacitinib citrate ER; two Claravis labeling supplements clearedAug 21Weekly roundup, 3 itemsTeva Pharmaceutical Industries Ltdtofacitinib
Sun Pharma logs eleven FDA labeling supplements and two REMS updates in one weekAug 14Weekly roundup, 11 itemsisotretinoinSun Pharmaceutical Industries
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