Drug Safety Labeling Changes - April  2015

Font : A-A+

Key to Label Sections

• C - Contraindications
• W - Warnings
• P - Precautions
• AR - Adverse Reactions

Drug Name	Sections Modified
	C	W	P	AR
Amlodipine Besylate and Benazepril - Capsules	-			-
Denosumab	-			-
Methylphenidate - Extended-Release Capsules	-	-	-
Aclidinium Bromide Oral Inhalation - Powder	-			-
Adderall (mixed salts of a single-entity amphetamine product) Tablets	-	-	-
Adderall XR (Dextroamphetamine mixed salts of a single entity amphetamine product) Capsules	-	-	-
Alendronate - Tablets and Oral Solution	-			-
Alendronate -Effervescent Tablets for Oral Solution	-			-
Alendronate/ Cholecalciferol Tablets	-			-
Atomoxetine - Capsules	-	-	-
Azilsartan Medoxomil /Chlorthalidone	-			-
Calcium Acetate - Oral Solution	-	-		-
Cetuximab	-			-
Clindamycin and Benzoyl Peroxide - Gel	-	-	-
Dexmethylphenidate - Tablets	-	-	-
Dexmethylphenidate- Extended-Release Tablets	-	-	-
Dextroamphetamine - Spansule Sustained Release Capsules	-	-	-
Diclofenac /Misoprostol - Oral Tablets	-		-
Etidronate - Tablets	-			-
Flucelvax (Influenza Vaccine)	-
Ibandronate - Injection	-			-
Ibandronate - Tablets	-			-
Isosorbide Dinitrate/ Hydralazine - Tablets		-		-
Itraconazole - Capsules and Oral Solution		-
Lisdexamfetamine - Capsules	-	-	-
Macitentan - Tablets	-	-	-
Maraviroc	-			-
Methadone - Tablets	-	-		-
Methamphetamine - Tablets	-	-	-
Methylphenidate - Chewable Tablets	-	-	-
Methylphenidate - Extended-Release Capsules	-	-	-
Methylphenidate - Extended-release Oral Suspension	-	-	-
Methylphenidate - Oral Solution	-	-	-
Methylphenidate - Sustained-Release Tablets	-	-	-
Methylphenidate - Tablets	-	-	-
Methylphenidate - transdermal system	-	-	-
Methylphenidate-Extended-release Tablets	-	-	-
Pazopanib -Tablets	-
Pomalidomide - Capsules	-
Primaquine - Tablets	-	-
Regorafenib - Tablets	-	-	-
Risedronate - Tablets	-			-
Risedronate - Delayed-Release Tablets	-			-
Risedronate -Tablets with Calcium Carbonate Tablets, USP	-			-
Saquinavir -Capsules and Tablets	-	-	-
Sildenafil - Tablets, Single Use Vials for Injection, and Oral Suspension		-	-	-
Simeprevir - Capsules	-
Sitagliptin - Tablets	-	-	-
Sitagliptin and Metformin - Extended Release Tablets	-	-	-
Sitagliptin and Metformin HCl - Tablets	-	-	-
Sunitinib Malate	-			-
Tadalafil - Tablets		-	-	-
Temozolomide - for Injection	-	-	-
Trastuzumab	-			-
Zoledronic Acid - 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