Drug Topics - January 14, 2008 - (Page 42) 42 DRUG TOPICS JANUARY 14, 2008 www.drugtopics.com > > > New Products Rx NEW DRUGS Novartis Pharmaceuticals, East Hanover, N.J., (862) 778-8300, has secured FDA approval for Tasigna (nilotinib) Capsules. The drug has been approved for the treatment of chronic-phase and acceleratedphase Philadelphia chromosome-positive chronic myeloid leukemia patients who are resistant or intolerant to prior therapy that included Novartis’ Gleevec Tablets. Azur Pharma, Exton, Pa., (484) 875-3010, is making available a new vegetarian form of Martek Biosciences’ DHA (docosahexaenoic acid) omega-3 in a prescription prenatal supplement. Natelle Plus provides essential vitamins and minerals plus at least 200 mg of Martek’s DHA. It is especially recommended for pregnant and nursing women. NEW INDICATIONS Bayer HealthCare Pharmaceuticals, Wayne, N.J., (973) 694-4100, along with Onyx Pharmaceuticals, Emeryville, Calif., (510) 597-6500, has received FDA approval for a new indication for Nexavar (sorafenib) Tablets. Originally approved for advanced kidney cancer, the oral anticancer drug is now used in the treatment of patients with unresectable hepatocellular carcinoma (primary liver cancer). Sanofi-aventis, Bridgewater, N.J., (908) 243-6000, and Bristol-Myers Squibb, Princeton, N.J., (609) 2524000, have received FDA approval for a new indication for Avalide (irbesartan). The antihypertensive drug is now indicated for initial use in patients likely to need multiple drugs to lower their blood pressure. Crestor (rosuvastatin calcium) has been approved for a new indication: as an adjunct to diet to slow the progression of atherosclerosis in patients with elevated cholesterol. Crestor is the product of AstraZeneca, Wilmington, Del., (800) 236-9933. NEW DOSAGE STRENGTHS Sprycel (dasatinib) is an oral inhibitor of multiple tyrosine kinases for the treatment of adults in all three phases of chronic myeloid leukemia (CML) with resistance or intolerance to prior therapy. Bristol-Myers Squibb has received FDA approval for new labeling that includes a lower recommended starting dose of 100 mg once daily. The lower dose reduces the incidence of some side effects while still preserving the efficacy of the drug for chronic-phase CML patients who no longer respond to other approved therapies. NEW DELIVERY SYSTEM EMD Serono, U.S. affiliate of Geneva-based Merck Serono, has received FDA approval for easypod, a new delivery system for the subcutaneous administration of Saizen, a treatment for growth hormone deficiency. The device is to be used in conjunction with Saizen click.easy cartridges. The company can be reached in Rockland, Mass., at (800) 283-8088. Cloderm (clocortolone pivalate) Cream 0.1% is now available in a new delivery system—the Cloderm Pump. The 30-gm container controls the amount of topical corticosteroid dispensed, minimizing waste and encouraging patient compliance. Cloderm Cream, a product of Coria Laboratories, Fort Worth, is indicated for the treatment of inflammation- and pruritus-associated dermatoses. The company can be reached at (817) 302-3800. ADVERTISERS INDEX ACTOS (Takeda Pharmaceuticals) . . INSERT,21 AMITIZA (Takeda Pharmaceuticals) INSERT,13 CARVEDILOL (Teva Pharmaceuticals USA) . . . 5 CORICIDIN (Schering-Plough) . . . . . . . . . . . IBC CORPORATE (McKesson) . . . . . . . . . . . . . . . . . . 1 CORPORATE (Mylan Pharmaceuticals) . . . . BC CORPORATE (Parata Systems) . . . . . . . . . . . . . 7 CORPORATE (QS/1 Data Systems) . . . . . . . . . 27 FLECTOR (Alpharma U.S. Pharmaceuticals) 43-44 HALFLYTELY (Braintree Labs) . . . . . . . . . . . 9-10 LEXAPRO (Forest Laboratories) . . . INSERT,25 MUCINEX (Adams Respiratory Therapeutics) . 3 NEBIVOLOL (Forest Laboratories) . . . . INSERT PEDIA-LAX (C.B. Fleet Co.) . . . . . . . . . . . . . . . . 31 SELZENTRY (Pfizer Inc.) . . . . . . . . . . INSERT,17 ZYPREXA (Eli Lilly) . . . . . . . . . . . . . . . . . . . . . . IFC IFC-Inside front cover IBC-Inside back cover BC-Back cover http://www.drugtopics.com
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