FDA actions in brief, February 2008

FDA has approved tadalafil 2.5 and 5 mg (Cialis, Lilly) for the once-daily treatment of erectile dysfunction (ED).

Fibrin sealant (human) (Evicel, Ethicon/Omrix) has been approved as an adjunct to hemostasis in general surgery.

FDA has approved 6% hydroxyethyl starch in 0.9% sodium chloride infusion (Voluven, Fresenius Kabi) for the treatment and prophylaxis of hypovolemia.

Valsartan (Diovan, Novartis) has been approved for the treatment of hypertension in children and adolescents aged 6 to 16 years.

Duloxetine (Cymbalta, Lilly) has been approved for the maintenance treatment of major depressive disorder in adults.

Triamcinolone injectable suspension (Triesence, Alcon) has been approved for visualization during vitrectomy and for the treatment of sympathetic ophthalmia, temporal arteritis, uveitis, and ocular inflammatory conditions unresponsive to topical corticosteroids.

FDA has approved 3 additional dosage strengths (20, 40, and 60 mg) of lisdexamfetamine (Vyvanse, Shire) for the treatment of attention-deficit/hyperactivity disorder (ADHD) in children aged 6 to 12 years.

FDA has approved a 1,000-mg formulation of metformin extended-release tablets (Glumetza, Depomed) for use alone or in combination with a sulfonylurea or insulin as an adjunct to diet and exercise to improve glycemic control in adult patients with type 2 diabetes.

FDA has approved new formulations of nisoldipine (Sular, Sciele) for the treatment of hypertension. The new dosages (8.5, 17, 25.5, and 34 mg) replace the previous formulations (10, 20, 30, and 40 mg).