Drug Safety Labeling Changes - January  2015

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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
Imatinib - Tablets	-			-
Nitroglycerin - Nitrolingual( Pumpspray) Spray
Abiraterone - Tablets	-	-		-
Benazepril -Tablets		-	-	-
Busulfan - Injection	-	-	-	-
Cilostazol - Tablets	-	-		-
Clarithromycin - Tabs, Granules, XL Filmtabs	-		-	-
Dalteparin - Injection	-			-
Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate				-
Everolimus - Tablets and Afinitor Disperz Tablets	-			-
Everolimus -Tablets	-			-
Ibrutinib - Capsules	-			-
Infliximab	-		-	-
Isosorbide Dinitrate -Tablets		-		-
Lisdexamfetamine - Tablets	-	-	-
Medroxyprogesterone - Injection	-
Milnacipran - Tablets	-			-
Minoxidil - Tablets	-	-
Modafinil - Tablets	-	-	-
Nilotinib - Capsules	-			-
Procardia Capsules and Procardia XL (Nifedipine) Tablets	-	-		-
Rocuronium - Injection	-			-
Valproic acid - Capsules and Oral Solution Divalproex Sodium Delayed Release Depakote ER Extended Release Tablets Depakote Sprinkle Capsules (Divalproex Sodium Coated Particles in Capsules) Depacon (Valproate Sodium) Injection	-			-
Zoledronic Acid - Injection	-			-
Zoledronic Acid - Injection	-			-

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