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Marlborough, Mass.-based Sepracor Inc., (877) SEPRACOR, has received FDA approval for Xopenex HFA (levalbuterol tartrate) Inhalation Aerosol, for the treatment or prevention of bronchospasm in adults, adolescents, and children four years of age and older with reversible obstructive airway disease.
NEW DRUGS Marlborough, Mass.-based Sepracor Inc., (877) SEPRACOR, has received FDA approval for Xopenex HFA (levalbuterol tartrate) Inhalation Aerosol, for the treatment or prevention of bronchospasm in adults, adolescents, and children four years of age and older with reversible obstructive airway disease. The hydrofluoroalkane metered-dose inhaler contains no chlorofluorocarbon propellant. Each canister provides 200 inhalations.
NEW INDICATIONS A new indication has been approved for Abilify (aripiprazole) Tablets and Oral Solution. The drug is now approved for maintaining efficacy in patients with bipolar I disorder with a recent manic or mixed episode who had been stabilized and then maintained for at least six weeks. Bristol-Myers Squibb, Princeton, N.J., (609) 252-4000, and Tokyo-based Otsuka Pharmaceutical are partners in the development and marketing of aripiprazole. Abilify was approved earlier for the treatment of acute bipolar mania, including manic and mixed episodes associated with bipolar disorder.
Avandia (rosiglitazone maleate), from GlaxoSmithKline, Research Triangle Park, N.C., (919) 483-2100, carries a new indication as part of triple therapy for treatment of Type 2 diabetes. It can now be used in combination with a sulfonylurea and metformin to treat this condition.
A new form of Clarinex features a gel control delivery system that supports 24-hour outdoor allergy relief. From Schering-Plough, Kenilworth, N.J., (908) 298-4000, Clarinex-D 24 Hour (desloratadine 5 mg and pseudoephedrine sulfate USP 240 mg) Extended Release Tablets relieve nasal and non-nasal seasonal allergic rhinitis, including nasal congestion, in patients 12 years of age and older. Clarinex was already approved in tablet and syrup formulations.
NEW GENERICS From Sicor Pharmaceuticals Sales, (800) 729-9991, subsidiary of TEVA Pharmaceuticals USA, comes methylprednisolone acetate injectable suspension USP. Available in 1-mL single-dose glass vials in 40 mg/mL and 80 mg/mL concentrations, it is AB rated to Pharmacia's Depo-Medrol Injectable Solution. The anti-inflammatory glucocorticoid is used for intramuscular, intralesional, and intrasynovial or soft tissue administration. It is indicated for treatment of endocrine, rheumatic, collagen, dermatologic, and allergic disorders, as well as for ophthalmic, gastrointestinal, respiratory, hematologic, neoplastic, edematous, and nervous system diseases.
Glades Pharmaceuticals, Duluth, Ga., (888) 445-2337, has received FDA approval for griseofulvin oral suspension USP 125 mg/5mL. This generic version of Johnson & Johnson's Grifulvin V systemically inhibits the growth of Trichophyton, Microsporum, and Epidermophyton fungi and is indicated for treating athlete's foot as well as ringworm of the body, thigh, nails, and scalp.
Torsemide tablets, in 5-, 10-, and 20-mg strengths, are available from Roxane Laboratories, Columbus, Ohio, (614) 272-4774. Roxane is a subsidiary of Boehringer Ingelheim Corp. Providing a generic alternative to Roche Therapeutics' Demadex, torsemide, a diuretic, is indicated for the treatment of edema associated with congestive heart failure, renal disease, and hepatic disease, as well as for the treatment of hypertension-alone or in combination with other antihypertensive agents. The tablets are available in 5-mg bottles of 100, 10-mg bottles of 100 and 10x10 unit-dose packages, and 20-mg bottles of 100 and 500 and 10x10 unit-dose packages.