Drug Safety Labeling Changes - NOVEMBER  2013

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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
Lisinopril -Tablets		-	-
Alendronate /Cholecalciferol - Tablets	-	-
Aliskiren - Tablets	-			-
Aliskiren and Amlodipine - Tablets	-			-
Aliskiren and Hydrochlorothiazide - Tablets	-			-
Aliskiren, Amlodipine and Hydrochlorothiazide - Tablets	-			-
Atorvastatin/Amlodipine -Tablets	-	-		-
Chloroquine - Tablets	-		-
Clobazam - Tablets and Oral Suspension	-			-
Crizotinib - Capsules	-			-
Daptomycin - for Injection	-	-	-
Golimumab - Injection	-
Infliximab - Lyophilized Concentrate for Injection	-			-
Lanreotide - Injection	-	-	-
Lansoprazole - 30 mg Delayed-Release, Amoxicillin - 500 mg Capsules and Clarithromycin - 500 mg Tablets			-
Lenalidomide - Capsules	-			-
Levocetirizine Dihydrochloride - Tablets and Oral Solution	-	-	-
Lisinopril/Hydrochlorothiazide - Tablets		-	-
Mitotane - Tablets	-
Nitrofurantoin - Oral Suspension	-	-	-
Pazopanib - Tablets	-	-	-
Pioglitazone - Tablet	-	-		-
Pioglitazone and Metformin Hydrochloride	-	-		-
Pioglitazone - Tablets	-	-		-
Posaconazole - Delayed-release tablets and Oral Suspension	-		-	-
Ruxolitini - Tablets	-		-	-
Sorafenib - Tablets	-		-	-

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