This content was written and submitted by the supplier. It has only been modified to comply with this publication’s space and style.
The "Summary Page" provides a listing of product names and safety labeling sections revised:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/ucm402776.htm
The following drugs had modifications to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS and PRECAUTIONS sections:
Alsuma (sumatriptan)
Androderm (testosterone)
AndroGel (testosterone) gel
Avalide (irbesartan and hydrochlorothiazide)
Aveed (testosterone undecanoate)
Axiron (testosterone)
Benicar (olmesartan medoxomil)
Benicar HCT (olmesartan medoxomil-hydrochlorothiazide)
Caverject (alprostadil for injection)
Caverject Impulse Dual Chamber System (alprostadil for injection)
Cerebyx (Fosphenytoin Sodium Injection)
Cleocin Phosphate (Clindamycin injection, USP) and (clindamycin injection in 5 percent dextrose)
Cleocin HCL (clindamycin hydrochloride)
Complera (emtricitabine, rilpivirine, tenofovir disoproxil fumarate)
Comtan (entacapone)
Delatestryl (testosterone enanthate)
Ella (ulipristal acetate)
Fortesta (testosterone) gel
Gazyva (obinutuzumab)
Herceptin (trastuzumab)
Hycamtin (topotecan)
Jetrea (ocriplasmin)
Lupron Depot (leuprolide acetate)
Nutropin AQ (somatropin [rDNA origin])
Prolia (denosumab)
Ravicti (glycerol phenylbutyrate)
Saizen (somatropin [rDNA origin])
Serostim (somatropin [rDNA origin] for injection)
Sporanox (itraconazole)
Striant (testosterone)
Sutent (sunitinib malate)
Symlin (pramlintide acetate)
Testim (testosterone)
Testosterone gel
Tev-Tropin (somatropin [rDNA origin])
Thalomid (thalidomide)
Tribenzor (olmesartan medoxomil, amlodipine, hydrochlorothiazide)
Trileptal (oxcarbazepine)
Votrient (pazopanib)
Xgeva (denosumab)
Zestril (lisinopril)
