Drug Safety Labeling Changes - February  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
Acitretin - Capsules	-	-	-	-
Arformoterol Tartrate Inhalation - Solution	-	-	-
Naproxen/Esomeprazole - Delayed-Release Tablets	-	-		-
Omeprazole/Sodium Bicarbonate - Capsules	-	-		-
Sitagliptin and Metformin HCl - Extended-Release Tablets	-	-	-	-
Tolvaptan - Tablets		-	-
Anagrelide - Capsules			-	-
Atomoxetine - Capsules	-	-	-
Azathioprine - Tablets and Injection	-		-	-
Boceprevir - 200 mg Capsules	-
Carbidopa	-
Dexamethasone - Intravitreal Implant	-	-	-
Eltrombopag - Tablets	-
Esomeprazole - Delayed-Release Oral Suspension	-	-		-
Esomeprazole - for Intravenous Injection	-	-		-
Eszopiclone - Film Coated Oral Tablets	-	-	-
Everolimus - Tablets for Oral Administration Everolimus - Tablets for Oral Suspension	-			-
Ezetimibe/Simvastatin - Tablets				-
Famotidine - Tablet	-	-	-
Golimumab - Injection For Intravenous Use	-			-
Ketoconazole - Tablet	-			-
Lomitapide Capsules	-	-		-
Lovastatin				-
Menotropins - for Injection				-
Omeprazole - Delayed-Release Capsules	-	-		-
Omeprazole - Delayed-Release Oral Suspension	-	-		-
Omeprazole/Sodium Bicarbonate - Powder for Oral Suspension	-	-		-
Palonosetron - Injection			-	-
Praziquantel Tablets	-	-
Rivaroxaban - Tablets	-	-		-
Simvastatin Tablets				-
Sitagliptin and Simvastatin - Tablets				-
Tacrolimus - Extended-Release Capsules	-
Urofollitropin - for Injection, Purified				-
VemurafenibTablets	-

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