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Sucampo Pharmaceuticals, Bethesda, Md., (301) 961-3400, along withTakeda Pharmaceuticals, will market newly approved Amitiza(lubiprostone).
Sucampo Pharmaceuticals, Bethesda, Md., (301) 961-3400, along with Takeda Pharmaceuticals, will market newly approved Amitiza (lubiprostone). The drug is indicated for the treatment of chronic adult idiopathic constipation not caused by disease or use of medication. Available as capsules, it works by increasing intestinal fluid secretion.
HepaGam B, a hepatitis B immune globulin, has been approved for Cangene Corp., a Winnipeg, Can.,-based biopharmaceutical firm. The agent, indicated for treatment following acute exposure to hepatitis B virus, will be distributed by Apotex Corp., Weston, Fla., (800) 706-5575.
Forest Laboratories, St. Louis, (800) 678-1605, has been given FDA approval for Aerospan (flunisolide HFA, 80 mcg) Inhalation Aerosol. The medication is indicated for the maintenance treatment of asthma as prophylactic therapy in adult and pediatric patients six years of age and older.
Upsher-Smith Laboratories, Minneapolis, (800) 654-2299, in a license agreement with Unigene Laboratories, Fairfield, N.J., has a nasal spray to treat osteoporosis in women with low bone mass who have been postmenopausal for more than five years. Fortical (calcitonin-salmon [rDNA origin]) Nasal Spray is recommended in conjunction with adequate intake of calcium and vitamin D.
ISTA Pharmaceuticals' Xibrom (bromfenac ophthalmic solution) 0.09%, approved last year for the treatment of ocular inflammation following cataract surgery, can now be used for treating pain following cataract surgery. It is a twice-daily topical nonsteroidal anti-inflammatory solution. ISTA, in Irvine, Calif., can be reached at ((949) 788-6000.
A new formulation of Clarinex has been approved for Schering-Plough, Kenilworth, N.J., (908) 298-4000. Clarinex-D 12 Hour Extended Release Tablets (desloratadine 2.5 mg and pseudoephedrine sulfate, USP 120 mg) have approval for the relief of nasal and non-nasal symptoms of seasonal allergic rhinitis (including nasal congestion) in patients 12 years of age and older. The new formulation uses a bi-layer tablet delivery system. Twice-daily dosing is recommended to control the symptoms of nasal congestion along with other allergy symptoms.
NEW DELIVERY SYSTEM
Kogenate FS (antihemophilic factor [recombinant], formulated with sucrose), the recombinant factor VIII hemophilia A treatment from Berkeley, Calif.-based Bayer HealthCare, is now available with BIO-SET needleless reconstitution system. Kogenate FS with BIO-SET involves fewer components for reconstitution, reduces the risk of accidental needlestick injuries during reconstitution, and is easily portable in its new smaller size. Bayer can be reached at (800) 288-8371.