New Rx, OTC, and generics (November 2010)

Key Points

New drugs

FDA has approved Bayer HealthCare's new oral contraceptive (OC) Beyaz (drospirenone/ethinyl estradiol/levomefolate calcium tablets and levomefolate calcium tablets). Beyaz is the first and only OC approved to raise folate levels in women using OC for birth control. Beyaz combines the hormone ingredients in the birth control pill YAZ (drospirenone 3 mg/ethinyl estradiol 20 µg) with 451 µg levomefolate calcium, a B vitamin. (888-842-2937)

FDA has approved Novartis' Gilenya capsules (fingolimod) to reduce relapses and delay disability progression in patients with relapsing forms of multiple sclerosis (MS). Gilenya is the first in a new class of drugs that block some blood cells in lymph nodes, reducing their migration to the brain and spinal cord, which may help reduce the severity of MS symptoms The drug will be available in 0.5 mg capsules. ( http://www.novartis.com/800-693-9993)

FDA has approved Novartis' Tekamlo tablets (aliskiren and amlodipine in once-daily 150 mg/5 mg, 150 mg/10 mg, 300 mg/5 mg, and 300 mg/10 mg dosage strengths), a single, combination-therapy product treating hypertension, for use alone or with other antihypertensive agents. It is approved as initial therapy for patients likely to need multiple drugs to meet blood-pressure goals and as replacement therapy when blood pressure is not adequately controlled with either aliskiren or amlodipine alone. ( http://www.novartis.com/800-693-9993)

New generics

FDA has approved Akorn's erythromycin ophthalmic ointment USP 1 g as a supplement to the company's already approved ANDA for erythromycin ophthalmic ointment USP 3.5 g. ( http://www.akorn.com/)

FDA has given final approval to Mylan's ANDA for tacrolimus capsules (0.5 mg, 1 mg, and 5 mg), the generic version of Astellas' Prograf capsules, a treatment to prevent rejection in people who have received certain organ transplants. ( http://www.mylan.com/)

Amneal has FDA approval to manufacture spironolactone HCl tablets in 25-mg, 50-mg, and 100-mg strengths. The AB-rated product is therapeutically equivalent to Aldactone (made by the Pharmacia & Upjohn unit of Pfizer). ( http://www.amneal.com/)