The FDA has accepted a New Drug Application for silodosin, a novel alpha1-adrenoreceptor antagonist, from Watson Pharmaceuticals, Inc., of Corona, Calif. Watson is seeking approval of silodosin for the treatment of BPH symptoms.

The FDA announced that Baxter Healthcare Corporation, of Deerfield, Ill., has temporarily stopped manufacturing multiple-dose vials of heparin due to reports of severe allergic reactions and hypotension in patients who receive high "bolus" doses of the drug.

AMAG Pharmaceuticals, Inc., of Cambridge, Mass., has announced that the FDA has accepted for standard review its New Drug Application (NDA) for ferumoxytol as an IV treatment of iron deficiency anemia in CKD patients.

Simcor (Niaspan/simvastatin), the first fixed-dose combination of two widely prescribed cholesterol therapies, has been approved for use along with diet to lower levels of elevated total cholesterol, LDL cholesterol, and triglycerides, and to raise HDL cholesterol in patients with complex lipid disease when treatment with monotherapies are not considered adequate.

Merck has received a not approvable letter from the FDA to its New Drug Application seeking approval for over-the-counter (OTC) Mevacor (lovastatin) 20 mg.

Tekturna HCT has been approved as a single-tablet combination of two medicines for high BP: tekturna (aliskiren), the first new type of antihypertensive drug in more than a decade, and the diuretic hydrochlorothiazide.

The FDA issued an Early Communication regarding its ongoing review of Vytorin (ezetimibe and simvastatin) based on preliminary results from the recently completed ENHANCE (Effect of Combination Ezetimibe and High-Dose Simvastatin vs. Simvastatin Alone on the Atherosclerotic Process in Patients with Heterozygous Familial Hypercholesterolemia) study on this cholesterol-lowering drug.

The FDA has approved Welchol (colesevelam hydrochloride) to reduce blood glucose in adults with type 2 diabetes mellitus in combination with metformin, sulfonylureas, or insulin, either alone or in combination with other agents, according to Daiichi Sankyo, Inc., of Parsippany, N.J.

Indevus Pharmaceuticals, Inc., of Lexington, Mass., has received a non-approvable letter from the FDA for Valstar (valrubicin solution), the only approved product for therapy of bacillus Calmette-Guérin-refractory carcinoma in situ of the urinary bladder.

Diovan (valsartan), an angiotensin receptor blocker (ARB) marketed by Novartis Pharmaceuticals of East Hanover, N.J., has been approved for treating hypertension in children and adolescents aged six to 16.