Indevus Pharmaceuticals, Inc., of Lexington, Mass., announced that it 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.

Depomed, Inc., of Menlo Park, Calif., has received approval for 1,000-mg strength tablets of Glumetza (metformin hydrochloride extended-release tablets), which is indicated alone or in combination with a sulfonylurea or insulin as an adjunctive therapy to improve glycemic control in adult type 2 diabetes patients.

The beta blocker Bystolic (nebivolol), a once-daily medication that can be used alone or in combination with other hypertension treatments, has received FDA marketing clearance.

The FDA has approved Cialis (tadalafil) for once-daily use (2.5 mg and 5 mg), an oral medication taken to treat erectile dysfunction (ED).