New products for pharmacists: Rx, OTC, and generics (February 2011)

Key Points

New drugs

Available from Meridian Medical: Alsuma (6 mg/0.5 mL sumatriptan) 2-pack single-dose prefilled auto-injector for acute treatment of migraine and cluster headaches. ( http://www.alsuma.com/ 877-770-8796)

Novartis has announced FDA approval of Amturnide (aliskiren/amlodipine/hydrochlorothiazide tablets in 5 dosage strengths: 150/5/12.5 mg, 300/5/12.5 mg, 300/5/25 mg, 300/10/12.5 mg, 300/10/2 mg), a fixed-dose combination hypertension therapy for patients not adequately controlled by any 2 drugs in the following classes: direct renin inhibitors, calcium channel blockers, and diuretics. ( http://www.pharma.us.novartis.com/ 800-693-9993)

FDA approved Watson's Ella (ulipristal acetate 30 mg), an oral emergency contraceptive tablet available by prescription for the prevention of unintended pregnancy for up to 5 days after unprotected intercourse or a known contraceptive failure. ( http://www.ella-rx.com/ 800-272-5525)

FDA has approved Endo Pharmaceuticals' Fortesta, a Schedule III controlled substance. The clear, odorless gel delivered by metered-dose pump treats hypogonadism (low testosterone) in men ≥18 years. ( http://www.endo.com/ 800-462-ENDO)

FDA approved Warner Chilcott's Lo Loestrin FE (norethindrone acetate and ethinyl estradiol tablets, ethinyl estradiol tablets, and ferrous fumarate tablets) for the prevention of pregnancy. With 10 µg of estrogen, Loestrin FE offers the lowest estrogen dose of any oral contraceptive on the U.S. market. (973-442-3200)

New generics

Glenmark Generics received final FDA approval for 2 products, indomethacin capsules in 25-mg and 50-mg strengths and sulfamethoxazole and trimethoprim tablets in double and single strengths. Indomethacin is used in treating arthritis; sufamethoxazole and trimethoprim tablets are indicated for urinary tract infections. (Fax: +91-22-4018-9988)