Elidel (pimecrolimus) Cream 1%, from Novartis Pharmaceuticals, East Hanover, N.J., (973) 781-8300, approved in December of 2001, is now available in 15-, 30-, and 100-gm tube sizes. Indicated for short-term and intermittent long-term treatment of mild to moderate atopic dermatitis, the product is claimed to be the first steroid-free prescription cream for mild to moderate eczema patients as young as two years of age. New phase III data underscore the safety, efficacy, and overall tolerability of the treatment with Elidel.
Uniretic (moexipril HCl/hydrochlorothiazide) tablets are now available in a new dosage strength of moexipril HCl 15 mg and hydrochloro-thiazide 12.5 mg for patients with hypertension. The antihypertensive product, from Schwarz Pharma, Milwaukee, (800) 558-5114, was already available in 7.5/12.5 mg and 15/25 mg. The new tablets are supplied in bottles of 100. The ACE inhibitor/diuretic combination medication is for therapy only in patients whose blood pressure is not adequately controlled with either moexipril or hydrochlorothiazide. The drug should be taken one hour before a meal.
Zometa (zoledronic acid for injection), from Novartis Pharmaceuticals, East Hanover, N.J., (973) 781-8300, has a newly approved second indication. Earlier approved for hypercalcemia of malignancy, it is now also indicated for treatment of patients with multiple myeloma and patients with documented bone metastases from solid tumors, in conjunction with standard antineoplastic therapy. The solid tumors include, among others, prostate cancer, lung cancer, and breast cancer. According to the company, Zometa is the first bisphosphonate proven effective for bone complications in these types of cancers.
Eisai Inc., Teaneck, N.J., (201) 287-2000, and Janssen Pharmaceutica, Titusville, N.J., (800) 523-6225, have received FDA approval for a new indication for the proton pump inhibitor Aciphex (rabeprazole sodium) to include the treatment of daytime and nighttime heartburn as well as other symptoms associated with gastroesophageal reflux disease (GERD). Aciphex was originally approved in 1999 for the healing of erosive GERD, maintenance of healed erosive GERD, and healing of duodenal ulcers.
A new formulation of albuterol is now available for asthma patients. Ventolin HFA (albuterol sulfate HFA inhalation aerosol), from GlaxoSmith-Kline, Research Triangle Park, N.C., (919) 483-2100, is a chlorofluorocarbon (CFC)-free formulation of Ventolin Inhalation Aerosol. The new short-acting bronchodilator, delivered by metered-dose inhaler, is indicated for the treatment or prevention of bronchospasm in adults and children four years of age and older with reversible obstructive airway disease.
The FDA has cleared a key health indicator for Rx use by patients at home. Metrika Inc., Sunnyvale, Calif., (877) 212-4968, is introducing A1cNow, a single- use device for measuring hemoglobin A1c (HbA1c) in diabetes control between physician visits. A simple fingerstick test can provide immediate, quantitative HbA1c results in eight minutes from a single drop of blood. According to the company, this type of testing is the best determinant of the body's average glucose metabolism over the previous two to three months.
Impax Laboratories, Hayward, Calif., (510) 476-2000, has been granted tentative approval for a generic version of the lipid-regulating agent Tricor (fenofibrate capsules), from Abbott Laborato-ries. The approval covers Fenofibrate Capsules (Micronized) in 67-, 134-, and 200-mg strengths. The drug is indicated for the treatment of very high serum triglyceride levels.
FDA approval has been granted to Ranbaxy Pharmaceuticals, Princeton, N.J., (609) 720-9200, for cefuroxime axetil tablets, providing a generic equivalent to GlaxoSmithKline's Ceftin. The oral cephalosporin is indicated for treatment of patients with infections caused by susceptible strains of designated organisms in pharyngitis and tonsillitis, lower respiratory tract infections, urinary tract infections, and skin and skin structure infections. Offered in 125-mg (base), 250-mg (base), and 500-mg (base), the tablets will be available in 20-count unit-of-use bottles and bottles of 60 and 100.
American Pharmaceutical Partners, Los Angeles, (800) 551-7176, has been given approval by the FDA for cefotaxime for injection, USP, the first generic version of the third-generation cephalosporin Claforan, marketed by Abbott Laboratories. This broad-spectrum cephalosporin antibiotic, for intramuscular and intravenous administration, is used in the treatment of such infections as those of the lower respiratory tract, the skin and skin structure, bones and/or joints, and central nervous system, as well as genitourinary, gynecologic, and intra-abdominal infections.
Newly approved for KV Pharmaceuticals, St. Louis, (314) 645-6600, is propafenone hydrochloride, a class I antiarrhythmic used in the treatment of life-threatening ventricular arrhythmias. The drug is available in 150-, 225-, and 300-mg. The branded drug, Rythmol, is manufactured by Knoll Laboratories.
Available from Sidmak Laboratories, East Hanover, N.J., (973) 386-5566, are fluoxetine capsules, USP, 10 mg and 20 mg. The SSRI, indicated for depression and obsessive-compulsive disorder, offers a generic alternative to Eli Lilly's Prozac. It will be available in bottles of 100, 500, and 1,000; the 20-mg capsules are available also in bottles of 2,000.
Warm Cream, a topical transdermal cream for warming cold hands and feet, is now available from Strategic Science & Technologies, Newton Center, Mass., (800) 679-4748. The specially formulated cream delivers the natural amino acid L-Arginine across the skin into the tissue below, where it is converted to nitric oxide to control local blood flow. As normal blood flow is restored, the afflicted areas are warmed.
Nutravail Technologies, Chantilly, Va., is launching Sport Safe DRIVE XP Performance Drink, a natural energy and electrolyte powder drink mix that also provides glucosamine for joint support. According to the company, the product is free of all banned substances as defined by the International Olympic Committee. The company can be reached at (800) 914-SAFE.
A handbag-sized air cushion, invented by a British Airways pilot, now offers a means to prevent blood stagnation in the legs of people forced to be seated for long periods of time, thus guarding against the development of deep vein thrombosis. The new Airogym foot cushion, from Airogym Ltd., London, is a small, inflatable footpad. Pressing the feet against the pad causes muscular contraction of the calf muscles, which improves the blood flow through the main veins to the heart to cut blood clot risk. Orders can be placed on line at www.airogym.com.
The Ableware adjustable shower seat with arms and back can now make personal hygiene easier for patients. From Maddak Inc., Pequannock, N.J., (973) 628-7600, the seat features height-adjustable legs, suction feet, and a built-in handheld shower spray holder and supports up to 300 lb. It retails for $59.90.
The French company ROC, owned by Johnson & Johnson, New Brunswick, N.J., (732) 524-0400, is introducing additions to its Retinol Actif Pur and Protient Lift lines. Two new skin care products, Retinol Actif Pur Anti-Wrinkle Cleansing Lotion and Protient Life Night Firming Cream offer, first, a cleanser that lifts impurities as it delivers Retinol to the skin to diminish the appearance of fine lines and wrinkles, at $8.99, and a skin-firming formula that tightens and moisturizes overnight, available for $19.99.
Nancy Jillard. New Product Newswire. Drug Topics 2002;6:65.