Drug Safety Labeling Changes - July  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
Acetaminophen and Caffeine - Tablets, Caplets and Geltabs	-	-		-
Azilsartan Medoxomil - Tablets	-	-		-
Azilsartan Medoxomil/ Chlorthalidone - Tablets	-	-		-
Desvenlafaxine - Extended-Release Tablets	-
Fluoxetine - Pulvules	-
Nexplanon - Etonogestrel implant, Radiopaque, Subdermal Use Only	-	-	-
Paroxetine - Tablets, Oral Suspension and Controlled-Release Tablets	-
Protriptyline - Tablets	-
Triamcinolone Acetonide Injectable Suspension	-		-	-
Ado-Trastuzumab Emtansine for Injection, for Intravenous Use	-
Amlodipine and Olmesartan Medoxomil - Tablets, for oral use	-	-		-
Betamethasone and Betamethasone Acetate Injection Suspension	-		-	-
Boceprevir - Capsules	-			-
Bupropion - Extended-Release Tablets	-
Bupropion - Sustained-Release Tablets	-
Calcitonin-salmon [rDNA origin]) Nasal Spray for Intranasal Use	-
Citalopram - Tablets	-
Clarithromycin - tablets, USP Clarithromycin - for Oral Suspension USP) Clarithromycin - extended release tablets	-	-	-
Clomipramine - Capsules	-
Desipramine -Tablets USP	-
Desvenlafaxine - Extended-Release Tablets	-
Desvenlafaxine - Extended-Release Tablets	-
Desvenlafaxine - Extended-Release Tablets	-
Dexamethasone - Phosphate Injection	-		-	-
Dextroamphetamine mixed salts of a single entity amphetamine product Capsules	-	-	-
Docetaxel - Injection	-
Doxepin - Capsules and Oral Concentrate	-
Duloxetine - Capsules	-
Eprosartan	-	-		-
Eprosartan /Hydrochlorothiazide - Tablets	-	-		-
Escitalopram -Tablets and Oral Solution	-
Everolimus - Tablets for Oral Administration	-
Everolimus - Tablets for Oral Suspension	-
Fluoxetine - Delayed Release Capsules	-
Fluoxetine - Tablets	-
Fluvoxamine - Extended-Release Capsules	-
Fluvoxamine -Tablets	-
Fondaparinux - Solution for Injection	-			-
Histrelin Acetate - Subcutaneous Implant	-			-
Humatrope (somatropin [rDNA origin] for injection)	-			-
Hydrocortisone - Injection and Sterile Powder for Injection	-		-	-
Imipramine - Capsules	-
Implanon - Etonogestrel Implant, For Subdermal Use	-	-	-
Indinavir	-	-	-
Leuprolide - Injection	-	-		-
Levomilnacipran - Extended- Release Capsules	-
Linaclotide - Capsules				-
Memantine - Extended-Release Capsules	-	-		-
Methylprednisolone - Injectable Suspension, USP	-		-	-
MethylPrednisolone - Sterile Powder for Injection	-		-	-
Mirtazapine - Tablets Orally Disintegrating Tablets	-
Nicardipine - Injection	-	-	-
Nortriptyline - Solution Nortriptyline Capsules	-
Olanzapine and Fluoxetine - Capsules	-
Oxcarbazepine - Film-Coated Tablets and Oral Suspension for Oral Administration	-			-
Paroxetine - Tablets	-
Rosuvastatin - Tablets	-	-	-
Ruxolitinib - Tablets	-			-
Selegiline - Orally Disintegrating Tablets	-			-
Sertraline - Tablets and Oral Concentrate	-
Tamsulosin - Capsules	-
Trazodone - Extended-Release Tablets	-
Trazodone - Tablets	-
Triamcinolone - USP Injectable Suspension	-		-	-
Triamcinolone Hexacetonide - Injection Suspension	-		-	-
Trimipramine - Capsules	-
Triptorelin - for Injectable Suspension Intramuscular use	-			-
Venlafaxine - Extended-Release Capsules	-
Venlafaxine - Extended-Release Tablets	-
Venlafaxine -Extended-Release Tablets	-	-		-
Vilazodone - Tablets	-
Vortioxetine - 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