Drug Topics - December 10, 2007 - (Page 40)

40 DRUG TOPICS DECEMBER 10, 2007 www.drugtopics.com > > > New Products Rx NEW DRUGS Allergan Inc., Irvine, Calif., (714) 246-4500, has FDA approval for Combigan (brimonidine tartrate/timolol maleate ophthalmic solution) 0.2%/0.5%. As an alpha adrenergic receptor agonist/beta adrenergic receptor inhibitor combination, Combigan is indicated for the reduction of elevated intraocular pressure (IOP) in patients with glaucoma or ocular hypertension who require adjunctive or replacement therapy due to inadequately controlled IOP. Auriga Laboratories is introducing a convenience kit containing Zytopic Cream (triamcinolone, USP 0.1%), the soap-free cleanser Cleré, and Emolene, a hypoallergenic moisturizer. Zytopic Cream is indicated for the relief of inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses The company is also launching Coraz Lotion (hydrocortisone lotion USP, 2%) in a convenience kit that contains Puleré medicated wash as well. Coraz is also approved for relieving inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Auriga is in Norcross, Ga., at (877) 2874428. NEW INDICATIONS Otsuka Pharmaceutical Co., Rockville, Md., (800) 321-1335, and Bristol-Myers Squibb, Princeton, N.J., (609) 252-4000, have received FDA approval for a new indication for Abilify (aripiprazole). The drug can now be used in the treatment of schizophrenia in adolescents 13 to 17 years of age. It was already approved for treating adults with schizophrenia. NEW DOSAGE STRENGTHS Cephalon Inc., Frazer, Pa., (610) 344-0200, has been granted approval for a 30-mg strength of Amrix (cyclobenzaprine hydrochloride extended-release capsules). Amrix is a once-daily skeletal muscle relaxant for the relief of muscle spasm associated with acute and painful musculoskeletal conditions. It was already available in 15 mg. NEW GENERICS Two drugmakers—Roxane Laboratories, Columbus, Ohio, (614) 272-4774, and Caraco Pharmaceutical Laboratories, Detroit, (313) 871-8400—have been granted FDA approval for oxcarbazepine tablets in 150-, 300-, and 600-mg strengths. As a generic alternative to Novartis’ antiepileptic drug Trileptal, oxcarbazepine is indicated as monotherapy or adjunctive therapy in the treatment of partial seizures in adults and in children four years of age and older. Caraco Pharmaceutical Laboratories has also been given the nod to market methimazole tablets, USP, in strengths of 5 mg and 10 mg. The drug, indicated for the treatment of hyperthyroidism, provides a therapeutic equivalent to the FDA’s reference listed drug in the Orange Book. Abraxis Pharmaceutical Products, Schaumburg, Ill., (847) 413-2075, has been granted three new approvals. Fludarabine phosphate will be marketed in two forms. The lyophilized version is the generic equivalent of Bayer HealthCare’s Fludara for Injection and will be packaged in 50 mg/2 mL single-dose vials. The liquid version is the equivalent of fludarabine phosphate for injection marketed by Teva Parenteral Medicines and will be packaged in a 50-mg single-dose vial. Fludarabine is indicated for the treatment of adult patients with B-cell chronic lymphocytic leukemia who have not responded to or whose disease has progressed during treatment with one or more standard alkylating agent-containing regimens. Epirubicin hydrochloride injection will be ADVERTISERS INDEX ACTOS (Takeda Pharmaceuticals) . . INSERT, 21 BROVANA (Sepracor Inc.) . . . . . . . . . . . . INSERT CEFOTETAN (Abraxis Pharmaceutical Partners) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . HSE7 CICLOPIROX (Fougera) . . . . . . . . . . . . . . . . . . . . . 3 CORPORATE (Mylan Pharmaceuticals) . . . . . . . 7 CORPORATE (QS/1) . . . . . . . . . . . . . . . . . . . . . . . . 27 CORPORATE (Teva Pharmaceuticals) . . . . . . . . . 9 DORIPENEM (Ortho-McNeil Pharmaceutical) . . . . . . . . . . . . . . . . . . . . . . HSE13 FLECTOR (Alpharma) . . . . . . . . . . . . . . . . . IBC, BC FREESTYLE (Abbott Laboratories) . . . . . . . . . . . 19 INVEGA (Janssen Pharmaceutica) . . . . HSE8-11 LEXAPRO (Forest Laboratories) . . . . INSERT, 17 METOPROLOL SUCCINATE (Ethex Corp.) . . 15 MUCINEX (Adams Respiratory Therapeutics) . . 5 NEBIVOLOL (Forest Laboratories) . . . . . INSERT NEUPRO (Schwarz Pharma) . . . . . . . . . . . . . 11-12 THROMBIN (King Pharmaceuticals) . HSE14-16 TYGACIL (Wyeth Pharmaceuticals) . . . . . HSE3-4 ZICAM (Matrixx Initiatives) . . . . . . . . . . . . . . . . IFC IFC-Inside front cover IBC-Inside back cover BC-Back cover http://www.drugtopics.com

Table of Contents Feed for the Digital Edition of Drug Topics - December 10, 2007

Drug Topics - December 10, 2007 Latebreakers Latebreakers in Depth Letters Health-System Edition - Cover Story Clinical Practice Professional Practice Special Report Technology Community Practice Unraveling Medicare 150 Years of American Pharmacy Rx Care In the Pipeline Cover Story: Fair or foul? Self-Care Chains and Business Government and Law Continuing Education: Natural Medicines for Bone Health New Products Advertisers Index Classified Viewpoint

Drug Topics - December 10, 2007

For optimal viewing of this digital publication, please enable JavaScript and then refresh the page. If you would like to try to load the digital publication without using Flash Player detection, please click here.