NEW PRODUCT NEWSWIRE

Rx

NEW INDICATIONS

Neurontin (gabapentin), a product of Pfizer Inc., New York City, (800) 438-1985, has been approved for a new indication: post-herpetic neuralgia (PHN). Approximately 10%-15% of patients with herpes zoster (shingles) develop this painful condition that can persist for months or even years. Neurontin was first approved in 1993 as an add-on treatment for partial epileptic seizures.

GlaxoSmithKline, Philadelphia, (888) 825-5249, has approval for an "as needed" indication for Flonase (fluticasone). According to the company, this indication could provide dosing advantage over triamcinolone and mometasone for management of nasal symptoms of seasonal and perennial rhinitis.

Vivelle-Dot (estradiol transdermal system), a twice-weekly estrogen replacement patch, is now approved in a new low dose for prevention of postmenopausal osteoporosis. Novogyne Pharmaceuticals, Miami, (888) NOW-NOVA, claims that its new 0.025 mg/day is the smallest such patch available for providing the lowest effective ERT dosage strength available. The four original dosage strengths (0.0375, 0.05, 0.075, and 0.1 mg/day) have been available for the treatment of menopausal symptoms since 1999, and they are now also indicated for prevention of postmenopausal osteoporosis.

NEW FORMULATIONS

Aventis Pasteur, Swiftwater, Pa., (800) 822-2463, has been given FDA approval for the first four doses of a new formulation of the DTaP vaccine that protects children from tetanus, diphtheria, and pertussis. The firm is pursuing licensure for a fifth-dose indication. Daptacel (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) is a slightly different formulation from that of Tripedia, the older version of the vaccine; both versions are sold by Aventis Pasteur. Daptacel will be manufactured in the company's Canadian facility, and Tripedia will continue to be produced in the United States.

Betaseron (interferon beta-1b) for subcutaneous injection, in a new room-temperature (25°C/77°F) formulation, has been approved for distribution in the United States. Betaseron treats relapsing-remitting multiple sclerosis. The new formulation, from Berlex Laboratories, Wayne, N.J., (973) 694-4100, provides greater convenience for MS patients, permitting more options for travel and storage. About 50% of people with relapsing-remitting MS advance to secondary progressive MS, a condition for which Betaseron is approved in Europe, Canada, and Australia.

NEW DOSAGE STRENGTH

Shire Pharmaceuticals Group plc, headquartered in Basingstoke, Great Britain, has received approval for three further strengths of Adderall XR (mixed salts of a single-entity amphetamine product), its once-daily treatment for attention deficit hyperactivity disorder (ADHD). The new 5-, 15-, and 25-mg capsules complement the existing 10-, 20-, and 30-mg capsules, thus providing physicians with more options to treat the condition. For further information, contact Shire US Inc., Florence, Ky., at (859) 282-2100.

Actonel (risedronate sodium tablets), codeveloped and comarketed by Procter & Gamble, Cincinnati, (800) 347-1565, and Aventis Pharmaceuticals, Bridgewater, N.J., (800) 207-8049, has approval for a new 35-mg once-weekly dosage strength. The approval offers patients a convenient dosing option for the treatment of postmenopausal osteoporosis.

NEW DELIVERY

Adenocard Ansyr syringes are now available from Fujisawa Healthcare, Deerfield, Ill., (847) 317-8800, for delivery of Adenocard (adenosine injection). These prefilled, needleless, plas-tic syringes are available in two color-coded, prefilled, single-dose sizes of 6 mg and 12 mg. Adenocard blocks AV nodal reentry to restore normal sinus rhythm in patients with paroxysmal supraventricular tachycardia. The disposable syringe, developed by Abbott Laboratories, offers a latex-free plastic delivery system that adapts to most connection valves to reduce the risk of accidental needlesticks.

NEW GENERICS

TEVA Pharmaceuticals USA, North Wales, Pa., (888) TEVAUSA, has received final approval for torsemide tablets, in 5-, 10-, 20-, and 100-mg strengths. The tablets provide a generic alterna- tive to Roche's Demadex tablets, a loop diuretic for treating hypertension and edema.

Taro Pharmaceutical Industries, Hawthorne, N.Y., (800) 544-1449, now has FDA clearance for amcinonide cream USP 0.1%. The high-potency topical cortico-steroid, used primarily in the management of inflammatory skin conditions, is bioequivalent to Cyclocort Topical Cream, from Fujisawa.

Barr Laboratories, Pomona, N.Y., (800) BARRLAB, has FDA approval for a generic version of Wyeth's Nordette tablets. The regimen of oral contraceptives contains levonorgestrel 0.15 mg and ethinyl estradiol 0.03 mg. The new Barr version will be marketed under the brand name Portia.

Approvable status to manufacture and market gabapentin, 100-, 300-, and 400-mg capsules has now been granted to Purepac Pharmaceutical, Elizabeth, N.J., (908) 527-9100, a subsidiary of Alpharma Inc. The capsules, which will bear the Purepac label, provide a generic equivalent for Pfizer's Neurontin capsules. The drug is indicated in the treatment of partial seizures of epilepsy.

A new graded-release formulation of diltiazem hydrochloride, for patients at risk of heart attack and stroke, is now available from Biovail Corp., Toronto, (416) 285-6000. The calcium-channel blocker, dosed at 10 p.m., provides significant reductions in blood pressure in the hours between 6 a.m. and noon, when patient risk is at its greatest.

Also from TEVA comes word of tentative approval for pravastatin sodium tablets in strengths of 10, 20, and 40 mg. The generic equivalent of Bristol-Myers Squibb's Pravachol tablets, the statin is indicated in the treatment of hyperlipidemia and the primary prevention of coronary events.

American Pharmaceutical Partners, Los Angeles, (800) 551-7176, has clearance from the FDA for pamidronate disodium injection. This is a bone-resorption inhibitor used to treat hypercalcemia associated with malignancy—with or without bone metastases—and Paget's disease. Available in 30- and 90-mg strength single-dose 10-ml vials, it provides a generic alternative to Aredia, from Novartis.

OTC

For those who love the outdoors but are vulnerable to poison ivy, oak, and sumac, a new product is available to completely remove the poisonous urushiol oil from the skin. Zanfel Poison Ivy Wash, a topical solution, promises to provide lasting relief from symptoms, usually within 30 seconds of its application. According to the manufacturer, Zanfel Laboratories, Morton, Ill., (800) 401-4002, this is the only product known to attach itself to the toxic oil and pull it from the skin at any stage after contact.

From Hero Nutritional Products, San Clemente, Calif., (800) 500-HERO, comes a new line of YummiBears. Pectin-based and gelatin free, Vegetarian Bears will be available as Vegetarian Multi- Vitamin and Mineral and Vegetarian Calcium Bears with Vitamin D. And for adults, Yummi-Bites Calcium will provide 500 mg of calcium and vitamin D in chocolate and strawberry flavors.

For health benefits associated with Omega 3 intake, Capsugel, the capsule technology division of Pfizer Inc., and YourVitamins Inc., Henderson, Nev., (800) 800-1200, have introduced ProCaps Essential Omega 3 Fish and Flax Oils. The Capsugel Licaps technology delivers proprietary blends of cold-water fish and flax oils in a hard-shell capsule that helps preserve purity, potency, and stability.

OleoMed America, Miami, (866) OLEOMED, in an agreement with Eckerd Corp., will begin selling its OleoMed olive oil nutritional supplements at Eckerd's Florida stores. The pharmaceutical-grade olive oil, a "subset" of extra virgin olive oil, is blended with vitamins, minerals, and herbals and offered as a dietary supplement in the form of soft-gel capsules. Olive oil consumption has been promoted as a health benefit in lowering the risk of breast cancer, colon cancer, and cardiovascular disease and in improving blood pressure. New OleoMed is available in 11 different formulas, including those for bone, blood pressure, energy, heart, immune system, and prostate.

Zilactin Baby Teething Swabs, from Zila Consumer Pharmaceuticals, Phoenix, (602) 266-6700, are newly available to provide a 10% concentration of the pain reliever benzocaine to ease a baby's sore gums at teething time. Grape-flavored and containing no saccharin, coloring dyes, or alcohol, the swabs are premedicated with a special ingredient to "cool" sore gums. Each package includes eight individually sealed and disposable swabs.

Home Health Care

Bayer Diagnostics, Tarrytown, N.Y., has FDA clearance for alternate-site testing (AST) for its blood glucose self-test monitors. AST, which allows patients to draw blood from different parts of the body where there are fewer nerve endings, provides people with diabetes greater flexibility in the choice of a monitor. Clearance has been granted for Bayer's Glucometer Elite, Glucometer Elite XL, and Glucometer DEX/DEX 2 diabetes care systems for the forearm, palm, abdomen, and thigh. Glucometer Elite uses single test strips; Glucometer Elite XL offers the added option of downloading test results; and Glucometer DEX/DEX 2 provides a test strip disk holding 10 tests. For more information, call (914) 524-2962.

Health & Beauty Care

New from Medtech Inc., Norwalk, Conn., (800) 443-4908, are Cutex Essential Care nail polish remover pads, in a new formula for moisturizing and softening the cuticles and nourishing and softening the nails. Individually wrapped, they are available in both acetone and nonacetone versions. One pad is able to clean 10 nails.

Cover Girl Cosmetics, a unit of Procter & Gamble, Hunt Valley, Md., (888) COVERGIRL, is introducing its new "Twilighting" collection, in sunset-inspired shades of brown, gold, and mauve, for eyes, nails, and lips. The line will be supported with print and in-store advertising. In addition, a shade dial will be available at in-store displays to assist customers in mixing and matching colors.

Xylifloss, distributed by CP2 Distribution, Evanston, Ill., (888) 586-9608, is now available in Rite Aid drugstores nationwide. This top-selling dental flosser from Finland is touted as both hygienic and ergonomically correct, with sufficient floss for more than 250 uses. An ingredient in the floss helps reduce plaque formation and curb the development of cavities.

From L'Oreal, New York City, (212) 818-1500, comes a skin care system that fights blemishes and conditions and maintains healthy skin in women aged 15-29. Pure Zone offers a new skin care regimen to eliminate impu-rities, unclog pores, and smooth the skin as it helps prevent and heal breakouts. There are three types of cleansers—for normal, oily, or combination skin; a pore-tightening astringent; and an oil-free moisturizer to hydrate, calm, and soothe the skin. A nondrying Spot Check solution can be applied to the skin if or when breakouts occur.

Schick Shaving Products, Milford, Conn., provides the choice of a refillable or a disposable shaver with its new Schick Xtreme 3. Both refillable and disposable versions claim closeness with no razor burn. For further information, call (800) 742-8377.

For skin problems that include dark spots, hyperpigmentation, freckles, and liver spots, Urist Cosmetics, Canada, has introduced a new three-part Skin Whitening System. The Skin Whitening Cream, Vitamin C Serum, and Advanced Daily Moisturizer with Sunscreen (SPF 15) and Antioxidants moisturize, exfoliate, and help lighten the skin by inhibiting melanin production. According to the company, twice-daily use can produce results within three to eight weeks. To order, and for more information, call (866) 341-1148, or visit the website at www.uristcosmetics.com/skin_whitening.htm .

Etc.

From Thomson MICROMEDEX, Greenwood Village, Colo., comes word that its handheld mobileMICROMEDEX can be downloaded to Pocket PC devices, thus making pertinent medical information available to clinicians regardless of their handheld device choice. For further information, call (800) 525-9083.

Available from Health Care Logistics, Circleville, Ohio, (800) 848-1633, is the Tru-Cut multi-tablet cutter, which breaks up to 17 tablets in half at once. A blade guard provides protection when the cutter is not in use, and blade replacements are available two to a package ... Also from Health Care Logistics are Lexan ID tags, preprinted with "Return To" messages to redirect boxes, carts, and drawers. Tags are available in clear and in white, 50 tags to a package.

 

Nancy Jillard. New Product Newswire. Drug Topics 2002;12:67.