A survey of new Rx, new generic, and new OTC products
FDA has approved AstraZeneca's Dutoprol, a once-daily treatment for hypertension combining the active ingredient metoprolol succinate extended relesase with a low-dose diuretic, hydrochlorothiazide. A 90-day prescription will cost $18.33 a month regardless of whether patients have insurance, and shipping and handling will be free. Dutoprol will also be available in retail pharmacies. ( http://www.dutoprol.com/ / 800-236-9933)
FDA has approved GlaxoSmithKline's Votrient (pazopanib) to treat patients with advanced soft tissue sarcoma (STS) who have received previous chemotherapy. The U.S. label states that the product's efficacy in treating patients with adipocytic STS or gastrointestinal stromal tumors has not been demonstrated. ( http://www.votrient.com/ / 888-593-5977)
Stiefel, a GlaxoSmithKline company, has received FDA approval for Fabior Foam (tazarotene) 0.1%. It is the only retinoid in a topical foam formulation for the treatment of acne vulgaris in patients =12 years of age. Acne vulgaris is the most common skin problem in the United States, affecting about 40 to 50 million Americans. The approval was based on two multicenter, randomized, double-blind, vehicle-controlled phase 3 trials that were conducted in the United States and Canada. The product is contraindicated in pregnancy and may cause fetal harm when administered in pregnant women. The most common adverse reactions were application-site irritation, application-site dryness, application-site erythema, and application-site exfoliation.