Tag Archives: Exforge HCT (amlodipine/valsartan/hydrochlorothiazide) tablets

MedWatch February 2012 Safety Labeling Changes

Posted on March 24, 2012 by Ws Revelations

Translation The MedWatch February 2012 Safety Labeling Changes posting includes 65 products with safety labeling changes to the following sections: BOXED WARNINGS, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS and PATIENT PACKAGE INSERT. The “Summary Page” provides a listing of drug names … Continue reading →

Posted in FDA 2012, FDA Label Change | Tagged Abilify (aripiprazole) Tablets, Amturnide (amlodipine/aliskiren/hydrochlorothiazide) tablets, and Injection, Angeliq (drospirenone and estradiol) tablets, Aptivus (tipranavir) Capsules and Oral Solution, Avalide (irbesartan/hydrochlorothiazide) tablets, Benicar (olmesartan medoxomil) Tablets, Beyaz (drospirenone/ethinyl estradiol/levomefolate calcium tablets and levomefolate calcium) tablets, Cardiogen-82 (Rubidium Rb 82 Generator), Crestor (rosuvastatin calcium) Tablets, Crixivan (indinavir sulfate) Capsules, Diovan HCT (valsartan/hydrochlorothiazide) Tablets, EES (erythromycin ethylsuccinate) Granules for oral suspension, Elestrin (estradiol gel), Ery-Ped liquid and PCE (erythromycin particles in tablets) 333 mg and 500 mg film coated tablets, Eryc (erythromycin delayed-release) capsules, Exforge HCT (amlodipine/valsartan/hydrochlorothiazide) tablets, Famvir (famciclovir) Tablets, February 2012, Hepsera (adefovir dipivoxil) tablets, Invirase (saquinavir mesylate) Capsules and Tablets, Kaletra (lopinavir/ritonavir) Tablets and Oral Solution, Lescol (fluvastatin sodium) Capsules, Lescol XL (fluvastatin sodium) Extended-Release Tablets, Letairis (ambrisentan) Tablets, Lexiva (fosamprenavir calcium) tablets and oral suspension, Lipitor (atorvastatin calcium) Tablets, Livalo (pitavastatin) tablets, Lotensin HCT (benazepril HCl and hydrochlorothiazide) Tablets, MedWatch, MedWatch February 2012 Safety Labeling Changes, Mevacor (lovastatin) Tablets, Natazia (estradiol valerate and estradiol valerate/dienogest) tablets, Norvir (ritonavir) oral solution and tablets, Oral Solution, Oral Suspension, Orally Disintegrating Tablets, Orencia (abatacept) for injection, Ozurdex (dexamethasone intravitreal) implant, Patanase (olopatadine hydrochloride) Nasal Spray, Phendimetrazine tartrate SR 105 mg capsules, Pravachol (pravastatin sodium) Tablets, Premarin (conjugated estrogens) Vaginal Cream, Prempro (conjugated estrogens/medroxyprogesterone acetate tablets) and Premphase (conjugated estrogens plus medroxyprogesterone acetate) tablets, Prezista (darunavir), Reyataz (atazanavir sulfate) Capsules, Rituxan (rituximab) Intravenous Injection, Safety Labeling Changes, Safyral (drospirenone/ethinyl estradiol/levomefolate calcium tablets and levomefolate calcium) tablets, Simcor (niacin ER/simvastatin) Tablets, Tekamlo (aliskiren/amlodipine) tablets, Tekturna (aliskiren) and Tekturna HCT (aliskiren/hydrochlorothiazide) Tablets, Valturna (aliskiren/valsartan) tablets, Vaseretic (enalapril maleate/hydrochlorothiazide) Tablets, Vasotec (enalapril maleate) Tablets, Viracept (nelfinavir mesylate) Oral Powder, Vytorin (ezetimibe/simvastatin) Tablets, Xalkori (crizotinib) Capsules, Yasmin (drospirenone/ethinyl estradiol) tablets, Zocor (simvastatin) Tablets, Zyvox (linezoid) Tablets and Oral Suspension | Comments Off