Drug Safety Labeling Changes - August  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 and Ipratropium	-	-	-
Artemether and Lumefantrine				-
Atomoxetine	-			-
Bactrim (Sulfamethoxazole and Trimethoprim) Tablet and	-		-	-
Bactrim DS (Sulfamethoxazole and Trimethoprim) Double-Strength Tablet	-	-	-	-
Bupropion				-
Captopril		-		-
Certolizumab	-	-		-
Cladribine	-
Cyclosporine	-
Delavirdine	-	-		-
Duloxetine	-	-	-
Efavirenz	-			-
Emtricitabine- Rilpivirine- Tenofovir	-			-
Enfuvirtide	-			-
Etravirine	-			-
Felbamate	-	-	-	-
Fesoterodine Fumarate	-
Gabapentin	-	-	-
Ipratropium Bromide	-			-
Ivacaftor	-	-	-
Lamotrigine	-			-
Linagliptin	-
Lisinopril	-	-		-
Lisinopril and Hydrochlorothiazide	-	-		-
Lovaza (Omega-3-Acid Ethyl Esters) Capsules	-			-
Maraviroc	-			-
Mometasone Furoate and Formoterol Fumarate	-	-	-
Moxifloxacin	-			-
Norelgestromin and Ethinyl Estradiol	-			-
Olanzapine	-	-	-	-
Olanzapine and Fluoxetine	-	-		-
Oxaliplatin	-			-
Paliperidone Palmitrate	-
Panitumumab Injection	-
PEG-3350 and Minerals	-			-
Perflutren Protein-Type A Microspheres	-		-
Pramipexole	-			-
Raltegravir	-			-
Ranibizumab	-			-
Rilpivirine	-			-
Sevoflurane	-		-	-
Sildenafil				-
Solifenacin	-	-	-
Sorafenib	-
Tenofovir	-			-
Tolterodine	-	-		-
Torasemide	-	-	-
Trobicin (Spectinomycin) for Injectable Suspension	-		-	-
Trospium Chloride	-
Valsartan
Valsartan and Hydrochlorothiazide	-
Venlafaxine	-	-		-

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