New and Generic Drug Approvals
Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
---|---|---|---|---|
Avandamet | metformin hydrochloride; rosiglitazone maleate | Tablet;Oral | Sb Pharmco | Labeling Revision |
Avandaryl | glimepiride; rosiglitazone maleate | Tablet;Oral | Sb Pharmco | Labeling Revision |
Avandia | rosiglitazone maleate | Tablet;Oral | Sb Pharmco | Labeling Revision |
Benicar Hct | hydrochlorothiazide; olmesartan medoxomil | Tablet;Oral | Daiichi Sankyo | Manufacturing Change or Addition |
Botox | onabotulinumtoxina | Vial; Single-Use | Allergan | Labeling Revision |
Botox Cosmetic | onabotulinumtoxina | Vial; Single-Use | Allergan | Labeling Revision |
Kynamro | mipomersen sodium | Solution;Subcutaneous | Genzyme Corp | Labeling Revision |
Pantoprazole Sodium | pantoprazole sodium | Tablet, Delayed Release;Oral | Perrigo R and D | Approval |
Rosiglitazone Maleate; Metformin Hydrochloride | rosiglitazone maleate; metformin hydrochloride | Tablet; Oral | Teva Pharms | Approval |
Xeljanz | tofacitinib citrate | Tablet;Oral | Pf Prism Cv | Labeling Revision |
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