Drug Safety Labeling Changes - APRIL  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
Histrelin Acetate - Subcutaneous Implant	-	-	-
(Liraglutide [rDNA origin]) Injection	-			-
Adapalene - lotion	-	-	-
Alendronate - Effervescent Tablets	-	-
Alendronate - Tablets and Oral Solution	-	-
Alendronate / Cholecalciferol - Tablets	-	-
Artemether/Lumefantrine	-			-
Belatacept - Intravenous Injection	-			-
Benztropine - Injection	-	-		-
Candesartan - Tablets
Candesartan Cilexetil Hydrochlorothiazide Tablets
Cyclobenzaprine Hydrochloride Extended Release Capsules	-			-
Cyclobenzaprine -Tablets	-
Dabigatran - Capsules	-
Doripenem - for Injection	-	-	-
Dutasteride and Tamsulosin - Capsules
Dutasteride Gelatin Capsules	-	-	-
Efavirenz,Emtricitabine,Tenofovir, Disoproxil Fumarate	-			-
Emtricitabine - Capsulests and Oral Solution	-			-
Etidronate - Tablets	-	-
Famicyclovir -Tablets	-	-	-
Fidaxomicin - Tablets				-
Golimumab - Injection	-			-
Histrelin Acetate - Subcutaneous Implant	-
Ibandronate - Injection
Ibandronate - Tablets	-	-
Incobotulinumtoxin A for Injection	-	-	-
Interferon Beta 1-a Injection	-	-		-
Lacosamide - Tablets, Injection and Oral Solution	-	-	-
Laronidase - solution for intravenous infusion	-	-	-
Lomitapide - Capsules	-			-
Pancrelipase - Delayed - Release Capsules	-	-	-
Quetiapine- Extended Release Tablets	-			-
Quetiapine -Tablets	-			-
Quinine - Capsules	-			-
Risedronate - Tablets	-	-
Risedronate Sodium Delayed Release Tablets	-	-
Risedronate with Calcium Carbonate Tablets	-	-
Telaprevir - Film Coated Tablets	-			-
Tenefovir - Tablets and Oral Powder	-			-
Tocilizumab Injection	-			-
Tolvapatan - Tablets	-
Treprostinil - Inhalation Solution	-	-	-
Ustekinumab - Injection	-	-	-
Zaleplon -Capsules	-	-	-
Zolpidem - Sublingual Tablets	-			-
Zolpidem - Tablets
Zolpidem- Extended Release 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