Drug Safety Labeling Changes - February  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
Bicalutamide - Tablets	-	-	-
Deferiprone - Tablets	-	-		-
Oxybutynin Hydrochloride - Extended Release Tablets	-			-
Alendronate - Effervescent Tablets for Oral Solution	-	-		-
Atorvastatin / Amlodipine Tablets	-	-	-
Baclofen - Injection	-			-
Calcitonin-Salmon Injection	-	-	-
Candesartan Cilexetil /Hydrochlorothiazide Tablets	-	-		-
Candesartan -Tablets	-	-		-
CISplatin - Injection, Sterile Aqueous Injection	-	-	-
Degarelix - for Injection Lyophilized Powder for Injection	-			-
Desflurane, USP Volatile Liquid for Inhalation
Dianeal Peritoneal Dialysis Solution in Plastic Container, Low Calcium Peritoneal Dialysis Solution in ULTRABAG Plastic Container, and Dianeal PD-2 Peritoneal Dialysis Solution in ULTRABAG Plastic Container	-		-	-
Exenatide - Injection	-			-
Galantamine - HBr Tablets, Oral Solution Galantamine - HBr Extended-Release Capsules	-			-
Goserelin - Implant	-			-
Humalog (insulin lispro [rDNA origin]) Injection	-			-
Humalog Mix 50/50 (50% insulin lispro protamine suspension /50% insulin lispro [rDNA origin]) Injection	-			-
Humalog Mix 75/25 (75% insulin lispro protamine suspension /25% insulin lispro [rDNA origin]) Injection	-			-
Humulin 70/30 (70% human insulin isophane suspension/30% insulin human injection, rDNA origin)	-			-
Humulin N NPH (human insulin isophane suspension [rNDA origin])	-			-
Humulin R (insulin human injection, USP [rDNA origin])	-			-
Insulin glulisine [rDNA origin] Injection	-			-
Lamivudine - Tablets and Oral Solution	-			-
Lantus (insulin glargine [rDNA origin]) Injection	-			-
Levemir (insulin detemir [rDNA origin]) Injection	-			-
Liraglutide [rDNA origin]) Injection	-			-
Minocycline - Oral Suspension	-		-	-
Mipomersen - Injection	-	-	-
Novolin N (NPH, human insulin isophane suspension [rDNA origin]) Injection	-			-
NovoLog (insulin aspart [rDNA origin]) Injection	-			-
NovoLog Mix 50/50 (50% insulin aspart protamine suspension and 50% insulin aspart [rDNA origin]) Injection	-			-
NovoLog Mix 70/30 (70% insulin aspart protamine suspension and 30% insulin aspart [rDNA origin]) Injection	-			-
Ospemifene - Oral Tablets		-	-
Pentoxifylline - 400 mg Extended-Release Tablets	-	-		-
Piroxicam - Capsules	-	-
Pramlintide Acetate Injection	-			-
Prazosin - Hydrochloride Capsules	-		-	-
Propylthiouracil - Tablets	-	-	-
Raltegravir - for Oral Suspension, Chewable Tablets, and Film-coated Tablets	-	-		-
Rivastigmine - Capsule and Oral Solution	-
Rivastigmine - Transdermal System	-
Rotigotine -Transdermal System	-
Temsirolimus - Injection	-	-	-
Voriconazole - Tablets, for Oral Suspension, and for 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