Drug Safety Labeling Changes - March  2014

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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
Esomeprazole - for Intravenous Injection, Delayed-Release Capsules, and Delayed-Release Oral Suspension	-			-
Maraviroc - Tablets	-			-
Sevoflurane and Sevoflurane Volatile Liquid for Inhalation	-		-	-
Sildenafil - Tablets, Injection and Oral Suspension	-			-
Valproic Acid - Delayed Release Capsules	-
Valsartan and Hydrochlorothiazide - Tablets	-	-
Vandetanib	-	-		-
Amlodipine/Valsartan - Tablets	-	-
Amlodipine/valsartan/Hydrochlorothiazide -Tablets	-	-
Asparaginase Erwinia Chrysanthemi	-			-
Cabazitaxel - Injection	-
Calcitonin-Salmon Nasal Spray and Injection, Synthetic	-
Clarinex D 12-HOUR and 24-HOUR Extended Release Tablets	-	-	-
Econazole - Cream	-	-		-
Estradiol - transdermal spray
Finasteride - Tablets	-	-	-
Fluconazole - Injection and Powder for Oral Suspension				-
Levetiracetam - Tablets, Extended Release Tablets, Oral Solution and Injection	-	-	-
Naproxen/Esomeprazole- Delayed-Release Tablets	-			-
Omeprazole - Delayed-Release Capsules and Oral Suspension	-			-
ProQuad Measles, Mumps, Rubella and Varicella Virus Vaccine Live	-	-	-
Rifaximin - Tablets	-			-
Rivaroxaban - Tablets, 10 mg	-			-
Sildenafil Citrate -Tablets	-			-
Sodium Iodide I-131 Therapeutic Solution		-	-
Sulfasalazine - tablets, USP Sulfasalazine - delayed release tablets, USP	-
Tofacitinib - Tablets	-			-
Trastuzumab	-			-
Valsartan - Tablets and Capsules	-	-
Varivax Varicella Virus Vaccine Live	-	-	-

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