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Novartis Corp., East Hanover, N.J., (973) 781-8300, and Celgene Corp., Warren, N.J., (732) 271-1001, have received approval from the FDA for dexmethylphenidate 10-mg and 20-mg tablets (under the brand name Focalin), a refined, single-isomer formulation of Ritalin for treatment of attention deficit hyperactivity disorder. The drug contains only the active isomer required for effective management of the symptoms of ADHD at half the dose of Ritalin, thus providing physicians greater treatment flexibility.
A higher-dose strength of Pravachol (pravastatin sodium) provides a new titration option for physicians treating patients with high cholesterol who are at risk for heart attack. Pravachol 80 mg, from Bristol-Myers Squibb, Princeton, N.J., (609) 252-4000, answers the need for higher-dose statin therapy. According to the company, Pravachol is the only member of the statin drug class that is indicated to reduce the risk of first or second heart attack and stroke in patients with elevated cholesterol or coronary heart disease, in addition to diet when diet and exercise are not sufficient. Pravachol, supplied in 10-, 20-, and 40-mg tablets, was introduced in 1991.
From Alpharma Inc. comes word that its subsidiary Purepac Pharmaceutical Co., Elizabeth, N.J., (908) 527-9100, has received FDA approval to manufacture and market diclofenac sodium extended-release tablets in 100-mg strength. The approval provides a generic alternative to Novartis' Voltaren-XR. Diclofenac sodium, a non-steroidal anti-inflammatory drug, is indicated for chronic therapy of osteoarthritis and rheumatoid arthritis.
Another treatment option is now available for patients with pulmonary tuberculosis. Barr Laboratories, Pomona, N.Y., (800) BARRLAB, has received the FDA nod for etham-butol hydrochloride tablets 400 mg, USP. This approval provides a generic equivalent to Myambutol tablets, from Dura Pharmaceuticals. According to the company, ethambutol should not be used alone but should be used in conjunction with at least one other antituberculosis drug.
Caraco Pharmaceutical Laboratories, Detroit, (313) 871-8400, has received FDA approval to manufacture and market oxaprozin tablets. Oxaprozin is an NSAID indicated in the treatment of osteoarthritis and rheumatoid arthritis. Oxaprozin provides a generic alternative to G. D. Searle's Daypro ... Caraco Pharma has also received preliminary drug approval for metformin hydrochloride, the generic form of Bristol-Myers Squibb's Glucophage. Metformin HCl is an oral antihyperglycemic drug used in the management of Type 2 diabetes mellitus.
Ranbaxy Pharmaceuticals, Princeton, N.J., (609) 720-9200, a wholly owned subsidiary of Ranbaxy Laboratories Ltd., has received tentative FDA approval for midazolam syrup, 2 mg (base)/mL. According to the company, the product is bioequivalent to Roche Laboratories' Versed Syrup, a benzodiazepine for oral administration. The product is indicated for use, in a monitored setting only, in pediatric patients for sedation, anxiolysis, and amnesia prior to diagnostic, therapeutic, or endoscopic procedures or before induction of anesthesia ... Ranbaxy has also received a provisional green light from the FDA for loratadine, in a 10-mg dosage formulation, for relief of nasal and non-nasal symptoms of allergic rhinitis. Another tentative approval has been given to Ranbaxy to market lisinopril + hydrochlorothiazide tablets, in 10/12.5 mg, 20/12.5 mg, and 20/25 mg. This follows closely on the tentative approval of lisinopril tablets as a single-entity formulation. Lisinopril + HCT, combining an ACE inhibitor with a diuretic, is indicated for the treatment of hypertension that is not controlled with initial therapy.
Cyclosporine oral solution, USP (modified), 100 mg/mL, from Sidmak Laboratories, East Hanover, N.J., (800) 922-0547, is now approved and available as an AB-rated drug bioequivalent to Novartis' Neoral oral solution. The immunosuppressant agent is indicated for the prophylaxis of organ rejection in kidney, liver, and heart transplant patients; for the treatment of severe rheumatoid arthritis in patients who have not responded satisfactorily to methotrexate; and for treatment of adult nonimmunocompromised patients with severe, recalcitrant plaque psoriasis who have failed to respond to other systemic therapies.
Tentative FDA approval for ciprofloxacin tablets, in 250-, 500-, and 750-mg strengths, has been accorded TEVA Pharmaceuticals USA, North Wales, Pa., (888) TEVA-USA. The approval offers a generic alternative to Bayer's Cipro. The broad-spectrum fluoroquinolone agent is indicated for treatment in a variety of bacterial infections.
United Research Laboratories/Mutual Pharmaceutical Co., Philadelphia, (215) 288-6500, has FDA approval for its ANDA for propafenone HCl tablets, in 150-, 225-, and (exclusively for this company) 300-mg strengths. The tablets are AB-rated and provide a generic equivalent to all three strengths of Rythmol, from Knoll Pharmaceutical Co. The drug is indicated for the treatment of documented ventricular arrhythmias.
Bio-Logic Aqua Technologies, Grants Pass, Ore., (800) FOR-MIST, has introduced Nature's Tears, an all-natural medical-standard spring water that affects only the aqueous layer of the eye's tear film. Delivered as a contaminant-free fine mist, it replenishes lost moisture to the eyes and moisturizes the eyelid skin and the skin surrounding the eyes. The dispenser is held 12-18 inches from the eyes, with no need to tilt the head or spread the eyelids. Misting the air around the face ensures an even application, and breathing the mist can refresh nasal passages. The product is available in a two-pack of 1-oz. atomizer containers for $13.95.
From Novartis Consumer Health, Summit, N.J., (908) 598-7800, comes Benefiber, an all-natural powder fiber supplement made from partially hydrolyzed guar gum, taken from the seed of the cluster bean. The company claims that Benefiber is taste-free, grit-free, and undetectable when mixed with liquid or soft foods or incorporated into favorite recipes. One tablespoon (4 gm) provides 3 gm of soluble fiber; adults can take up to 5 tbs. per day toward the recommended fiber complement of a healthy diet. The product, packaged in 24- and 42-serving canisters and 14-count packets, will be available next month at a cost of approximately $8 for 24 servings.
For the greater convenience of America's 16 million patients with diabetes, Roche Diagnostics, Indianapolis, (317) 845-2000, has available its new Accu-Chek Compact Meter for blood glucose monitoring. Its proprietary Automated Drum Technology automates a strip-handling process with self-contained strips, calibrates the meter, and enables the test strips to be dispensed from a drum of 17 tests. The product delivers results within 15 seconds and requires only 3.5 µL of capillary blood. It also provides an infrared data port that can download data into Accu-Chek management systems, computers, and other data storage devices for forwarding, via modem, to healthcare providers.
New from Novo Nordisk Pharmaceuticals, Princeton, N.J., (800) 727-6500, is a "virtually painless" device for the administration of insulin. InnoLet insulin doser is a prefilled disposable doser that was designed to replace the vial-and-syringe method of insulin delivery for people with Type 2 diabetes. It is available without prescription with both Novolin 70/30 and Novolin. The design of the device facilitates injection stability and control over injection depth as well as decreasing tremor or movement at the needle tip.
Health Care Logistics, Circleville, Ohio, (800) 848-1633, is offering the convenience of a hands-free emesis bag that slips over a patient's head, encircling the neck to collect the emesis, regardless of state of consciousness of the patient. Its hands-free feature increases provider safety by reducing infectious waste contact. An outer wire rim can be adjusted to keep the bag open.
The Ableware AbleRise Bed Rail, from Maddak Inc., Pequannock, N.J., (973) 628-7600, provides convenient storage for bed patients, while offering support in and out of bed to help prevent falls. Rail slides between mattress and box spring make installation simple for twin, full, queen, and king-size beds, and nonmetal handles eliminate possible static shock. The item lists for $199.
Nancy Jillard. New Product Newswire. Drug Topics 2002;3:67.
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