Drug Safety Labeling Changes - January  2016

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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
Alosetron Hydrochloride Tablets	-	-	-	-
Aripiprazole - Tablets, Orally Disintegrating Tablets, Oral Solution, and Injection for INTRAMUSCULAR USE ONLY Aripiprazole - for Extended-release Injectable Suspension, for Intramuscular Use	-	-	-
Carbachol - Intraocular solution, USP	-		-
Carfilzomib - for Injection	-			-
Clindamycin - Solution, Lotion, and Gel, 1 Percent	-	-	-
Enalapril - 1 mg/mL Powder (reconstituted) for Oral Solution	-			-
Eribulin mesylate - Injection	-			-
Golimumab - Injection	-			-
Golimumab - Injection, for Intravenous Infusion	-			-
Hyaluronidase - Human Injection	-	-		-
Ibuprofen - lysine Solution	-	-	-
Iloperidone - Tablets		-	-
Lomustine - Capsules	-	-	-	-
Ombitasvir, Paritaprevir and Ritonavir - Tablets	-	-		-
Ombitasvir, Paritaprevir, and Ritonavir -Tablets; Dasabuvir -Tablets	-	-		-
OnabotulinumtoxinA	-			-
Oritavancin Diphosphate - Lyophilized Powder for Injection				-
Pentoxifylline - Tablets	-	-		-
Pramipexole - Tablets Pramipexole- Extended-Release Tablets	-	-	-
Propylthiouracil - Tablets	-			-
Ranolazine - Extended-Release Tablets	-	-	-
Telmisartan/ Amlodipine - Tablets	-	-
Topotecan - Injection	-	-	-	-
Trandolapril - Tablets	-			-
Trandolapril/ Verapamil - Tablets	-			-
Treprostinil - 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