Drug Safety Labeling Changes - AUGUST  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
Eribulin Mesylate - Injection	-	-	-
Levofloxacin - Tablets, Oral Solution and Injection	-
Peg-3350 & electrolytes For oral solution	-
Roflumilast - Tablets	-			-
Ambrisentan - Tablets
Atazanavir Sulfate Capsules	-	-	-
Atomoxetine - Capsules				-
Bedaquiline - Tablets	-	-	-	-
Ciprofloxacin - Extended-Release Tablets	-
Ciprofloxacin - Tablets and Oral Suspension	-
Ciprofloxacin - Tablets and Oral Suspension	-
Degarelix - for Injection	-	-	-
Denosumab - Injection				-
Doxorubicin - Liposome Injection	-
Flunisolide - Inhalation Aerosol	-	-		-
Gadodiamide - Injection		-	-	-
Gadofosveset Trisodium Injection	-			-
Gadoversetamide - Injection		-	-	-
Gemifloxacin - Tablets	-		-	-
Glimepiride - Tablets	-	-	-
Guanfacine - Extended-release Tablets	-	-	-
Ibritumomab Tiuxetan - Injection	-			-
Levonorgestrel-Releasing Intrauterine System	-			-
Levonorgestrel-Releasing Intrauterine System	-			-
Mesalamine - Delayed-Release Tablets	-		-	-
Methamphetamine - Tablets	-			-
Methylnaltrexone Bromide - Subcutaneous Injection	-			-
Methylphenidate - Extended-release Oral Suspension	-			-
Moxifloxacin - Tablets and Injection	-
Norfloxacin - Tablets	-
Pazopanib -Tablets	-			-
Rivaroxaban - Tablets	-
Rosuvastatin - Tablets	-
Sunitinib Malate Capsules	-

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