Drug Safety Labeling Changes - September  2012

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Key to Label Sections

• C - Contraindications
• W - Warnings
• P - Precautions
• AR - Adverse Reactions

Drug Name	Sections Modified
	C	W	P	AR
	-	-	-	-
Abiraterone acetate	-	-	-
Aggrenox (aspirin/extended release dipyridamole) 25 mg/200 mg Capsules	-
Albuterol (Salbutamol)	-	-	-
Amlodipine , Hydrochlorothiazide and Olmesartan	-	-	-	-
Amlodipine and Olmesartan		-		-
Amlodipine and Valsartan
Amlodipine, Valsartan and Hydrochlorothiazide
Benazepril		-		-
Benazepril HCl and Hydrochlorothiazide		-		-
Cayston (aztreonam for inhalation solution)	-	-	-	-
Cefepime	-
Clobetasol Propinate	-	-	-	-
Deferasirox
Denosumab	-	-	-	-
Dexlansoprazole	-	-	-	-
Doxorubicin		-	-	-
Dronedarone	-	-	-	-
Enalapril	-	-	-	-
Enalapril and Hydrochlorothiazide	-	-	-	-
Eprosartan	-	-	-	-
Eprosartan Mesylate Hydrochlorothiazide	-	-	-	-
Esomeprazole	-
Fenofibric Acid	-
Formoterol	-	-	-	-
Indacaterol
Irbesartan		-		-
Lansoprazole	-	-	-	-
Levalbuterol HCl	-	-	-
Levocetirizine	-			-
Linagliptin	-	-	-
Losartan		-		-
Lovaza (omega 3-acid ethyl esters) Capsules	-
Miglitol	-	-	-	-
Moexipril HCl Hydrochlorothiazide Tablets	-	-	-	-
Montelukast	-	-	-
Mycophenolatemofetil	-	-	-	-
Naproxen and Esomeprazole Magnesium	-
Olmesartan		-		-
Omeprazole	-	-	-	-
Ozurdex (dexamethasone intravitreal implant) 0.7 mg
Paclitaxel	-	-	-	-
Pantoprazole	-	-	-	-
Quinapril		-		-
Quinapril HC- Hydrochlorothiazide Tablets		-		-
Rotavirus vaccine	-	-	-	-
Simvastatin and Sitagliptin
Telmisartan	-	-	-	-
Testosterone Fortesta	-	-	-	-
Trandolapril	-	-	-	-
Trandolapril- Verapamil		-	-
Voltaren Ophthalmic (diclofenac sodium ophthalmic solution) 0.1%	-	-
Zolmitriptan	-

2016 - Monthly Summary Report for Drug Label Changes

2015 - Monthly Summary Report for Drug Label Changes

2014 - Monthly Summary Report for Drug Label Changes

2013 - Monthly Summary Report for Drug Label Changes

2012 - Monthly Summary Report for Drug Label Changes