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Novartis Pharmaceuticals, East Hanover, N.J., (862) 778-8300, has been granted a new indication for Femara (letrozole tablets).
RxNEW INDICATIONS Novartis Pharmaceuticals, East Hanover, N.J., (862) 778-8300, has been granted a new indication for Femara (letrozole tablets). The drug is now the first therapy approved by the FDA for the extended adjuvant treatment of postmenopausal women with early breast cancer who have received adjuvant tamoxifen therapy for five years.
NEW FORMULATIONS Campath (alemtuzumab for injection), from Berlex Inc., Montville, N.J., (973) 487-2000, is being marketed in a new, single-dose vial. The new formulation, which contains 30 mg/mL of Campath, will be three times the concentration of the currently marketed Campath ampoule, which will be discontinued shortly after the availability of the new form. No filtering is required during preparation. Campath is a humanized monoclonal antibody approved for B-cell chronic lymphocytic leukemia in patients who have failed treatment with both alkylating agents and fludarabine.
The Paris-based Sanofi-Aventis group has FDA clearance to market Allegra-D 24-Hour tablets (fexofenadine HCl 180 mg/pseudoephedrine HCl 240 mg), in a once-daily dosing formulation, for the treatment of seasonal allergy symptoms with nasal congestion in patients 12 years of age and older. For further information, contact Aventis Pharmaceuticals, Bridgewater, N.J., (800) 207-8049.
NEW DOSING Concerta (methylphenidate HCl) Extended-release Tablets have received approval for a 72-mg dosing regimen for use in adolescents with attention deficit hyperactivity disorder. There is no 72-mg tablet, but a once-daily dose of two 36-mg tablets is recommended. The manufacturer is McNeil Consumer & Specialty Pharmaceuticals, Fort Washington, Pa. For information on Concerta, call (888) 440-7903.
NEW LABELING Hoffmann-La Roche, Nutley, N.J., (973) 235-5000, has been granted a label change by the FDA for Xenical (orlistat). The weight-loss medication, indicated for obesity management, has been found in the XENDOS study to delay the onset of Type 2 diabetes in obese or overweight patients with impaired glucose tolerance. Xenical works locally in the gastrointestinal tract to reduce dietary fat absorption, which helps promote weight loss. The delaying effect with regard to Type 2 diabetes is believed to be due to the additional weight loss that accompanies Xenical treatment rather than the direct effects of the drug on glucose or insulin metabolism.
NEW DELIVERY SYSTEM Access Pharmaceuticals, Dallas, (214) 905-5100, has received FDA clearance for OraDisc A, a new proprietary mucoadhesive patch that gradually erodes when placed on the inside of the mouth, releasing active ingredient over a period of time. The new platform technology offers an improved delivery system for amlexanox, previously approved for the treatment of canker sores in patients 12 years of age and older with a normal immune system.
Ferring Pharmaceuticals, Suffern, N.Y., (845) 770-2600, is introducing a new device enabling needle-free reconstitution of the company's human-derived fertility treatments. Q-Cap will be packaged with Ferring's Bravelle (urofollitropin for injection, purified).
NEW GENERICS TriMarc Laboratories, Oklahoma City, (405) 942-3040, is introducing two prescription medications: Benzoyl Peroxide 5% and Benzoyl Peroxide 10%, available immediately. Benzoyl Peroxide Gel 5% and Benzoyl Peroxide Gel 10% are indicated for the topical treatment of mild to moderate acne vulgaris, and it may be used with other acne treatments.
Cilostazol tablets, in 50- and 100-mg strengths, are shipping from Prasco Laboratories, Cincinnati, (513) 618-3333. A generic version of Otsuka America Pharmaceutical's Pletal, cilostazol is indicated for the reduction of symptoms of intermittent claudication.
Barr Laboratories, Woodcliff Lake, N.J., (201) 930-3300, will manufacture and market a generic version of Bristol-Myers Squibb's Glucophage XR, in 750-mg strength. Metformin hydrochloride extended-release tablets are indicated as monotherapy, along with diet and exercise, for the improvement of glycemic control in patients 17 years of age and older with Type 2 diabetes.