Drug Safety Labeling Changes - June  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
Adalimumab	-
Bendamustine Hydrochloride	-
Bupropion	-	-	-
Ceftazidime and Avibactam	-	-
Cobicistat				-
Dapagliflozin
Dapagliflozin and Metformin HCl - Extended-Release
Darunavir -Tablet and Oral Suspension	-
Dolutegravir	-	-		-
Doxazosin	-	-		-
Doxercalciferol			-
Everolimus	-
Filgrastim	-	-	-	-
Fosphenytoin	-	-		-
Ibrutinib	-	-	-
Ibuprofen	-		-	-
Leuprolide - for depot suspension	-	-	-	-
Levocetirizine - Oral Tabs Levocetirizine -Oral Solution	-	-	-
Levonorgestrel and Ethinyl Estradiol	-		-	-
Macitentan	-	-	-
Medroxyprogesterone acetate	-	-	-
Nitisinone	-
Nitroglycerin		-		-
Ombitasvir, Paritaprevir and Ritonavir - Tablets		-		-
Ombitasvir, Paritaprevir and Ritonavir tablets; dasabuvir tablets	-	-		-
Oseltamivir - Capsules and Oral Suspension	-
Panobinostat	-			-
Parathyroid hormone	-			-
Phenytoin - Injection and Oral Suspension	-	-
Piperacillin and Tazobactam for injection	-
Pomalidomide	-	-
Ponatinib	-
Quetiapine	-	-	-
Rasburicase	-
Regorafenib	-			-
Sapropterin	-	-
Tacrolimus - Extended Release	-	-		-
Taliglucerase alfa	-	-	-
Teriflunomide
Treprostinil	-
Vigabatrin -Tablet Vigabatrin - Oral Solution	-
Ziv-aflibercept 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