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The LidoSite Topical System, recently launched by B. Braun Medical, Bethlehem, Pa., (610) 691-5400, is a topical anesthetic system for use in hospitals. The system uses a prefilled, one-time-use topical patch and a preprogrammed controller. The disposable patch contains lidocaine and epinephrine. When activated by means of a mild current, it repels the drug molecules away from the drug reservoir in the patch and into the skin. The analgesic takes effect in approximately 10 minutes and can last up to 60 minutes to a depth of 6.4 mm and across a 5 cm2 circle for superficial dermatologic procedures.
A new indication has been approved for GlaxoSmithKline's Flovent HFA inhalation aerosol. The corticosteroid, already approved for maintenance treatment of asthma in adults and adolescent patients 12 years and older, can now be used in children ages four through 11. GSK can be reached in Research Triangle Park, N.C., at (919) 483-2100.
Erbitux (cetuximab), already approved for use in combination with irinotecan to treat colorectal cancer, can now be used along with radiation therapy for treating patients with advanced squamous cell cancer of the head and neck. It has also been approved as monotherapy to treat head and neck cancer that has metastasized in spite of standard chemotherapy. Manufactured by ImClone Systems, Erbitux will be marketed by Princeton, N.J.-based Bristol-Myers Squibb, (609) 252-4000.
Genentech, South San Francisco, (650) 225-1000, and Cambridge, Mass.-based Biogen Idec have received approval for a new indication for the therapeutic antibody Rituxan (rituximab). It can now be used in combination with methotrexate to treat moderately to severely active rheumatoid arthritis in patients with inadequate response to one or more tumor necrosis factor antagonist therapies.
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Apidra (insulin glulisine [rDNA origin] injection) is a rapid-acting mealtime insulin analog that is newly available in the United States. A product of the Sanofi-Aventis Group, Bridgewater, N.J., (908) 243-6000, it is indicated to control hyperglycemia in lean to obese adults with Type 1 and Type 2 diabetes.