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Summary View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- May 2006

 

The summary view includes drug products with safety labeling changes to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, or ADVERSE REACTIONS sections. The “quick view” table below provides the drug name and sections modified. Click on the drug name to go to the detailed view. The detailed view includes sections and subsections modified, a description of new or modified safety information in the Boxed Warning, Contraindications, or Warnings sections and a link to the revised prescribing information.

Key: BW=BOXED WARNING, C=CONTRAINDICATIONS, W=WARNINGS, P=PRECAUTIONS, AR=ADVERSE REACTIONS

 
DRUG NAME SECTIONS MODIFIED

(Click on drug name to go to detailed view)

BW

C

W

P

AR

Thalomid (thalidomide) Capsules X X   X X

(Click on drug name to go to detailed view)

BW

C

W

P

AR

Cesamet (nabilone) Capsules   X X X X

(Click on drug name to go to detailed view)

BW

C

W

P

AR

Capozide (captopril and hydrochlorothiazide tablets, USP)     X X X
Retrovir (zidovudine) Tablets, Capsules, and Syrup     X X  

(Click on drug name to go to detailed view)

BW

C

W

P

AR

Androderm (testosterone transdermal system)       X  
Avandamet (rosiglitazone maleate and metformin HCl) Tablets       X X
Cubicin (daptomycin for injection)       X X
Gleevec (imatinib mesylate) Tablets       X X
Lexiva (fosamprenavir calcium) Tablets       X  
5.4% NephrAmine (essential amino acid injection)       X  
Noroxin (norfloxacin) Tablets       X X
Remicade (infliximab) for IV Injection       X  
Sandostatin LAR Depot (octreotide acetate for injectable suspension)       X  
Velcade (bortezomib) for Injection       X X

Vfend I.V. (voriconazole) for Injection

Vfend (voriconazole) Tablets

Vfend (voriconazole) for Oral Suspension

      X  
Zetia (ezetimibe) Tablets       X X

(Click on drug name to go to detailed view)

BW

C

W

P

AR

HalfLytely and Bisacodyl Tablets Bowel Prep Kit (PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution and bisacodyl delayed release tablets)

        X

Neurontin (gabapentin) Capsules, Tablets, and Oral Solution

        X

Zometa (zoledronic acid) Injection

        X

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