New Product Newswire
FDA approval for a new indication of Aciphex (rabeprazole) has been given to Eisai Inc., Teaneck, N.J., (201) 287-2000, and its comarketer, Janssen Pharmaceutica, Titusville, N.J., (800) JANSSEN. The proton pump inhibitor was approved in 1999 for short-term (four to eight weeks) treatment in the healing and symptomatic relief of erosive or ulcerative gastroesophageal reflux disease (GERD), healing of duodenal ulcer, and treatment of pathological hypersecretory conditions. The new approval carries the indication for daytime and nighttime heartburn and other symptoms associated with GERD.
Par Pharmaceuticals, Spring Valley, N.Y., (845) 425-7100, has acquired the U.S. rights to five Bristol-Myers Squibb products: Capoten (captopril) and Capozide (captopril and hydrochlorothiazide), antihypertensive drugs; the cholesterol-lowering Questran and Questran Light (cholestyramine); and Sumycin (tetracycline), an antibiotic.
NeoSan Pharmaceuticals, a business unit of Wilmington, N.C.-based aaiPharma Inc., (800) 575-4AAI, has entered into an agreement to purchase the U.S. rights to the Darvon (propoxyphene hydrochloride) and Darvocet (propoxyphene napsylate with acetaminophen) family of pain products from Eli Lilly.
IVAX Corp., Miami, Fla., (305) 575-4105, and TEVA USA, North Wales, Pa., (888) TEVA USA, have been given the FDA's nod for the 5-, 10- and 15-mg strengths of buspirone hydrochloride tablets. The antianxiety agent, which provides a generic alternative to Bristol-Myers Squibb's BuSpar, is used in the management of general anxiety disorders or the short-term symptoms of anxiety.
Par Pharmaceutical has also received approval for three new strengths of buspirone: 5, 10, and 15 mg. Par is already marketing the 7.5-mg strength of the agent.
Newly approved for United Research Laboratories/Mutual Pharmaceutical Co., Philadelphia, (215) 288-6500, is metformin hydrochloride 500-, 850-, and 1000-mg strength tablets. The approval provides a generic alternative to Bristol-Myers Squibb's Glucophage, an oral antiglycemic drug indicated as an adjunct to diet to lower blood glucose levels in Type 2 diabetes.
There are two new ANDA approvals for Gensia Sicor Pharmaceuticals, Irvine, Calif., (949) 455-4700: pamidronate di-sodium injection and a bioequivalent version of an ifosfamide/ mesna kit. As the generic alternative to Novartis' bisphosphonate Aredia, pamidronate is used to treat moderate or severe hypercalcemia associated with malignancy and moderate to severe Paget's disease. The new ifosfamide/ mesna kit, which offers a generic version of Bristol-Myers Squibb's IFEX/ MESNEX Injection Kit, will include the first approved liquid formulation of ifosfamide in a polymer vial, according to Gensia. The chemotherapeutic agent is used in the treatment of testicular cancer ... The company will also be launching mesna injection, approved earlier. The product, offering a generic alternative to Mesnex, from Bristol-Myers Squibb, is a chemotherapy agent used in combination with other chemotherapy drugs in the treatment of germ-cell testicular cancer in those patients not tolerant of or responsive to other drugs used in first- or second-line therapy. Mesnex is generally used along with ifosfamide to protect the bladder from the irritating effects of ifosfamide.
Bedford Laboratories, Bedford, Ohio, (440) 232-3320, will also market pamidronate disodium injection as a generic alternative to Aredia. The bone-resorption inhibitor is indicated in the treatment of hypercalcemia associ- ated with malignancy; Paget's disease; and osteolytic bone metastases of breast cancer and osteolytic lesions of multiple mye-loma.
Schiff, Salt Lake City, (801) 975-5000, has introduced a revised formulation of niacin containing five times the active ingredient of its previous formulation. Schiff niacin contains 500 mg of niacin per tablet. According to the company, this formulation makes it easier for consumers to ingest in just four tablets the 2,000 mg per day that, according to the New England Journal of Medicine, helps to promote cardiovascular health and maintain cholesterol levels in the normal range.
From PhytoPharmica, Green Bay, Wis., (800) 553-2370, come two new herbal products formulated to reduce joint pain and stiffness. FlexAgility, containing ginger (Zingiber officinale) and greater galangal (Alpinia galanga), helps reduce occasional joint overuse without gastrointestinal side effects. The product is available in 60-count bottles of softgels. Glucosamine sulfate-750 is a higher-potency formulation of the company's dietary supplement for building and supporting joint cartilage.
The QuickTek Blood Glucose System and the QuickLance all-in-one lancing system are now available for diabetes patients. QuickTek requires a small sample of blood, with test results obtainable in 10 seconds. Results are stored with time and date in a 250-test memory and are downloadable to a PC. QuickLance's design eliminates the need for a separate lancing device. After use, the needle retracts to protect against acciden- tal needlesticks or cross- contamination. For further information, contact the man-ufacturer, Hypoguard, Edina, Minn., (952) 646-3200.
Now there's a seat for the whole family. Maddak Inc. offers the Ableware family toilet seat and lid. The child's seat, which pulls down from the lid to rest atop the larger adult seat, can be removed for cleaning when not in use. Of durable, flexible plastic, the item fits all standard toilets.
A new Kidz-Med medicine dispenser is now available for administering liquid medicines to infants and toddlers. A reservoir, attached to a pacifier, holds up to 5 ml and delivers the medication by means of a plunger or by the baby's normal sucking. All parts are securely welded together for safety, according to the company, and may be sterilized to prevent reinfection. For further information, call Lord Richard Imports, New Paltz, N.Y., (877) 206-3225.
From Health Care Logistics, Circleville, Ohio, (800) 848-1633, come several new products. A locking refrigerator, fitting the Pyxis Remote Manager, helps keep medications under uniform temperature. It comes equipped with automatic defrost, interior light, removable shelves, covered door compartments, and adjustable thermostat ... Small enough to fit into a purse, briefcase, glove compartment, or emergency box, the compact personal toilet kit provides reusable male- and female-version cups, disposable bags containing sanitizing gelling powder, and cleansing cloths ... The ShotBlocker is a plastic device with an opening in the center to accommodate a needle. Pressed against an injection site, it helps to eliminate the pain of an injection via multiple blunt skin contact points on its underside that block the flow of pain signals to the brain ... A new convenience item for consumers and pharmacists is a metered pump nasal spray bottle that delivers 0.1 cc for a consistent dose. The white polyethylene plastic bottles are sold 12 to a package ... An electronic pill box timer-clock beeps every four to six hours, or as programmed, for up to 60 seconds, to remind patients to take their medications. The required LR-44 button cell battery is included.
A unit-dose packaging system for solid and liquid medications is available from DAKMED, Buffalo, (716) 852-3301. Light in weight and easily stored, the system comes with two blister sizes to accommodate various-size tablets and capsules, three sizes of liquid cups, an automatic heat sealer, and computerized labeling capability.
Thomson Corp.'s MICROMEDEX, Greenwood Village, Colo., (303) 486-6535, and PatientKeeper Inc., Brighton, Mass., (617) 987-0300, are together unveiling mobileMICROMEDEX for PatientKeeper's Mobilizer Platform. MICROMEDEX will deliver its clinical content to PatientKeeper's hand-held patient-monitoring device, making this information readily available to pharmacists and other healthcare professionals in mobile healthcare settings.
Nancy Jillard. New Product Newswire. Drug Topics Apr. 1, 2002;146:87.