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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