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Berlex, a U.S. affiliate of Schering AG, Germany, said today that the FDA has approved Yaz (3 mg drospirenone/20 mcg ethinyl estradiol), a new monophasic oral contraceptive. Yaz will be available in the U.S. by prescription in April, 2006.
Salix Pharmaceuticals announced that the FDA has granted marketing approval for prescription OsmoPrep tablets (sodium phosphate monobasic monohydrate, USP, and sodium phosphate dibasic anhydrous, USP). OsmoPrep tablets are indicated for cleansing of the colon as a preparation for colonoscopy in adults 18 years of age or older. OsmoPrep is patent protected until 2013, and additional patent protection is being sought through 2024.
Barr Pharmaceuticals said it was informed by FDA that additional clinical data will not be required to support the approval of Duramed Pharmaceuticals New Drug Application (NDA) for Seasonique (levonorgestrel/ethinyl estradiol tablets 0.15 mg/0.03 mg and ethinyl estradiol tablets 0.01 mg) extended-cycle oral contraceptive. The company said it will continue to work with FDA to resolve outstanding issues including product labeling and post marketing commitments.
CV Therapeutics announced that the company has begun filling orders and shipping Ranexa (ranolazine extended-release tablets) to pharmaceutical wholesalers.On Jan. 27, 2006, the FDA approved Ranexa for marketing in the US. The approval of Ranexa marks the first new pharmaceutical approach to treat angina in more than 20 years in the US.
Jazz Pharmaceuticals announced that Xyrem (sodium oxybate) oral solution is now available for patients with narcolepsy who suffer from excessive daytime sleepiness.