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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.
Medicis Pharmaceutical Corp., Scottsdale, Ariz., (602) 808-8800, has received FDA approval for a broadened indication for Vanos (fluocinonide 0.1% topical cream). The Class I corticosteroid was originally indicated for the treatment of plaque-type psoriasis. It can now be used as a primary therapy for all inflammatory and pruritic skin conditions in patients age 12 and older which are responsive to cortico-steroids. Applied once or twice daily, it treats such conditions as eczema and poison ivy.
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.
NEW DOSAGE STRENGTHS
Metadate CD CII
Metadate CD CII (methylphenidate HCl, USP) Extended-Release Capsules are now available in 40-, 50-, and 60-mg strengths from UCB Pharma, Smyrna, Ga., offering greater flexibility in dosing. The capsules, used in the treatment of attention deficit hyperactivity disorder, were already available in 10-, 20-, and 30-mg strengths, with a recommended starting dose of 20 mg once per day. The new strengths will allow immediate release of 30% of the formulation early in the day, with less drug action during evening meals and at bedtime. Dosing may be adjusted in 10-to 20-mg increments to a maximum of 60 mg per day. UCB Pharma can be reached at (800) 477-7877.
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