Drug Safety Labeling Changes - June  2012

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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
Albuterol (Salbutamol)	-	-	-
Atomoxetine
Azithromycin	-			-
Bendamustine hydrochloride	-	-		-
Bepotastine		-	-
Darunavir	-
Desogestrel and Ethinyl Estradiol	-	-		-
Dopamine	-	-	-
Dutasteride	-			-
Dutasteride And Tamsulosin	-			-
Efavirenz	-			-
Estradiol				-
Helidac Therapy (bismuth subsalicylate, metronidazole tablet and tetracycline hydrochloride) capsule	-		-
Interferon Alpha- Two B	-	-	-	-
Lisinopril	-			-
Mecasermin [rDNA origin] Injection	-	-	-
Methergine (methylergonovine maleate) tablet and injection	-
Modicon (norethindrone/ethinyl estradiol)	-	-		-
Mycophenolatemofetil	-			-
Myfortic (mycophenolic acid) delayed-release tablets	-			-
Norfloxacin	-	-	-
Norgestimate and ethinyl estradiol	-	-		-
Noxafil (posaconazole) Oral Suspension		-	-	-
Ortho Tri-Cyclen (norgestimate/ethinyl estradiol) Tablets	-	-		-
Ortho Tri-Cyclen Lo (norgestimate/ethinyl estradiol) Tablet	-	-		-
Ortho-Novum (norethindrone/ethinyl estradiol) 1/35 Tablets	-	-		-
Ortho-Novum (norethindrone/ethinyl estradiol) 7/7/7 Tablets	-	-		-
Peginterferon Alfa 2 B	-	-	-	-
Pemetrexed	-	-	-
Privigen Immune Globulin Intravenous (Human) 10% Liquid	-			-
Solifenacin	-			-
Telaprevir	-			-
Ustekinumab				-
Verteporfin	-	-
Zileuton	-	-		-

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