The "Summary Page" provides a listing of drug names and safety labeling sections revised.
The following drugs had modifications to the BOXED WARNINGS, CONTRAINDICATIONS and WARNINGS sections:
Atacand HCT (candesartan cilextetil/hydrochlorothiazide)
Benicar (olmesartan medoxomil)
Sporanox (itraconazole)
Twynsta (telmisartan/amlodipine)
Zestoretic (lisinopril/hydrochlorothiazide)
Zestril (lisinopril)
Benlysta (belimumab)
Celexa (citalopram hydrobromide)
Enablex (darifenacin)
Incivek (telaprevir)
Janumet (sitagliptin and metformin fixed-dose combination)
Januvia (sitagliptin)
Kombiglyze XR (saxagliptin/metformin hydrochloride extended-release)
Lidocaine in 5% Dextrose Injection
Magnevist (brand of gadopentetate dimeglumine)
Revlimid (lenalidomide)
Reyataz (atazanavir sulfate)
Treximet (sumatriptan and naproxen sodium)
Votrient (pazopanib)
Zometa (zoledronic acid)
Zmax (azithromycin extended release)
You are encouraged to report all serious adverse events and product quality problems to FDA MedWatch.
Companies in this press-release
