New Product Newswire
NEW PRODUCT NEWSWIRE
Salix Pharmaceuticals, Raleigh, N.C., (919) 862-1000, is launching Azasan in 75- and 100-mg strength tablets. Azasan (azathioprine) is an immunosuppressive agent used for the treatment of rheumatoid arthritis and related diseases.
Fragmin (dalteparin sodium injection) has received an additional indication: the prevention of deep vein thrombosis (DVT) or pulmonary embolism (PE) in acutely ill patients whose mobility is severely restricted. The clot-preventing agent, from Pfizer Inc., New York City, (800) 438-1985, had already been approved for prophylaxis (when used with aspirin) of certain ischemic complications and for preventing DVT/PE in patients undergoing hip replacement or abdominal surgery.
A reformulated, low-aluminum infusion multivitamin, M.V.I. Adult, is available in a pharmacy bulk package from aaiPharma, Wilmington, N.C., (800) 575-4224. The adult parenteral multivitamin product is also available in single-dose and univial presentations.
NEW DOSAGE STRENGTH
Wyeth Pharmaceuticals, St. Davids, Pa., (800) 666-7248, is making available the lowest effective dose of Prempro (conjugated estrogens/medroxyprogesterone acetate tablets). Prempro 0.3 mg/1.5 mg, with 52% less estrogen and 40% less progestin than the 0.625 mg/2.5 mg strength, has been shown effective in relieving menopausal symptoms with less breakthrough bleeding and breast tenderness. The medication is intended for women who have not had a hysterectomy.
NEW DOSING REGIMEN
Daiichi Pharmaceutical Corp., Montvale, N.J., (877) 324-4244, has received approval from the FDA for a once-daily dosing regimen of the antibiotic ear drop Floxin Otic (ofloxacin otic solution) 0.3% for the treatment of otitis externa (OE). The ototopical solution can be used in children as young as six months of age. A clinical study among pediatric and adult populations found a cure rate of 91% in the prescribed once-daily seven-day regimen for OE. Floxin Otic 0.3% was approved by the FDA in 1997 and is indicated forin addition to OEacute otitis media with tympanostomy tubes in patients one to 12 years of age and chronic suppurative otitis media in patients 12 years of age and older.
An injectable form of amiodarone HCl has been approved for International Medication Systems, South El Monte, Calif., (626) 442-6567. Amiodarone injection, 50 mg/ml, in 3-ml and 18-ml prefilled syringes, is indicated for initiation of treatment and prophylaxis of frequently recurring ventricular fibrillation and hemodynamically unstable ventricular tachycardia in patients refractory to other therapy or who cannot take oral medication. The drug provides a generic version of Wyeth's Cordarone.
TEVA Pharmaceuticals USA, North Wales, Pa., (888) TEVA USA, has introduced Budeprion SR (bupropion HCl extended-release tablets), an aminoketone anti-depressant. Available in 100-mg strength and indicated for the relief of depression, the drug provides a bioequivalent alternative to GlaxoSmithKline's Wellbutrin SR.
A new methadone label has been approved for aaiPharma for its parenterally administered and formerly branded Dolophine Injection. Methadone hydrochloride injection is approved for the management of moderate to severe pain unresponsive to non-narcotic analgesics and for use as temporary treatment of opioid dependence in patients unable to take oral medication.
Mercaptopurine tablets, USP, 50 mg, a generic alternative to Gate Pharmaceutical's Purinethol Tablets, have been approved for Roxane Laboratories, Columbus, Ohio, (614) 272-4774. Available in bottles of 25 and 250 tablets, the product is indicated for remission induction and maintenance therapy of acute lymphatic leukemia in pediatric or adult patients. For more effective initial remission, mercaptopurine should be given in combination with another chemotherapy agent.
Tentative approval has been granted to American Pharmaceutical Partners, Schaumburg, Ill., (800) 743-7082, for ciprofloxacin for intravenous infusion. Final approval will provide a generic alternative to Bayer's Cipro I.V., indicated for treatment of urinary tract, lower respiratory, nosocomial pneumonia, skin and skin structure, bone and joint, and complicated intra-abdominal infections.
Lupin Pharmaceuticals, Baltimore, (410) 576-2000, has been cleared to market cefixime suspension 100 mg/5 ml in the United States under its original Wyeth brand name of Suprax. The oral antimicrobial agent is used for the treatment of infections caused by susceptible bacteria.
There is a new generic approval for the treatment of attention deficit disorder with hyperactivity and exogenous obesity: methamphetamine hydrochloride tablets, USP, in 5-mg strength. The product, approved for Able Laboratories, South Plainfield, N.J., (908) 754-2253, is a generic version of Ovation Pharmaceuticals' Desoxyn Tablets, 5 mg.
Velivet (desogestrel/ethinyl estradiol) tablets, a generic alternative to Organon's Cyclessa, have been approved as a triphasic, 28-day-regimen oral contraceptive. The product contains tablets in the strengths of 0.100 mg desogeststral/0.025 mg ethinyl estradiol, 0.125 mg/0.025 mg, and 0.150 mg/0.025 mg. Barr Laboratories, Woodcliff Lake, N.J., (800) 222-0190, is launching this branded generic immediately.
Approved late last year, PEG-Intron REDIPEN is now being launched by Schering-Plough, Kenilworth, N.J., (908) 298-4000. The pen delivers individualized, weight-based dosing of PEG-Intron (peginterferon alfa-2b) Powder for Injection as therapy for chronic hepatitis C. REDIPEN is available in 50-, 80-, 120-, and 150-mcg strengths. Powder and sterile water are mixed together inside the pen just prior to delivery, then self-administered through the small 30-gauge needle.
Altovis is a dietary supplement for fighting fatigue and providing long-lasting energy. The proprietary once-daily formulation, from Berkeley Premium Nutraceuticals, Cincinnati, (800) 258-6847, contains essential vitamins and minerals in addition to other energy-boosting nutrients ... Rovicid, another Berkeley product, offers potent plant sterols for lowering cholesterol. The once-daily dietary supplement helps to block the absorption of cholesterol. In addition to phytosterol, it provides vitamin E, niacin, folic acid, calcium, zinc, and selenium ... Also from Berkeley comes Rogisen, a once-daily supplement to improve night vision and ocular health. Its blend of nutrients includes vitamins, minerals, and antioxidants.
Carrying calcium along as you go has become easier with the new VIACTIV Soft Calcium Chews available in a To-Go Pack. Taken twice a day, preferably with meals to enhance the calcium absorption, these chews also provide vitamins D and K, and only 20 calories and a half-gram of fat. The product is from McNeil Nutritionals, Fort Washington, Pa., (215) 273-7000.
Oona Health Inc., New York City, (888) 596-5154, offers two new PMS products for women. OonaPMS1 provides herbal nutrients as a hormone balanceone tablet contains chaste tree berry extract and black cohosh; an additional tablet offers passionflower extract. OonaPMS2, to be taken just before the menstrual period begins, utilizes ginger and a proprietary cramp bark extract to mitigate menstrual cramping, nausea, and heavy bleeding.
Purdue Pharma, Stamford, Conn., (800) 877-5666, is resuming shipment of four of its products. Betadine microbicide defends against topical infection and is used for presurgical cleansing to hand and skin degerming; Colace stool softener (docusate sodium) is used as a treatment for occasional constipation; Gentlax Tablets provide overnight relief of constipation; and enteric-coated Slow-Mag Tablets supply magnesium and calcium.
Health & Beauty Care
Nature's Gate, Los Angeles, (323) 516-8500, adding to its beauty and health products, has introduced Organics French Milled Bar Soaps and Organics Liquid Soap, both containing botanical extracts, essential oils, and floral waters. The bar soaps are available in Lavender and Aloe, Lemongrass and Clary Sage, Chamomile and Lemon Verbena, and fragrance-free Soy Milk. The liquid soaps offer a choice of Lavender and Aloe, Lemongrass and Clary Sage, Neroli Orange and Chocolate Mint, and Tea Tree and Blue Cypress.
Also from Nature's Gate, there's Cocoa Butter Body Stick for soothing dry skin. Claiming 85% organic ingredients, along with vitamins E and A, the cocoa butter formula helps fight dryness, prevent stretch marks and fine lines, and improve the elasticity of the skin.
"You Gotta Have Sol!" That's the new summer color collection from Cover Girl, Hunt Valley, Md., (410) 785-7300. The collection includes Tanfastic Bronzer, with compact and brush; six new WetSlicks for the lips; Eye Enhancers 3-Kit in three shades of pink; CG Smoothers Tinted Moisture SPF 15, an oil-free moisturizer; and new shades in Continuous Color Nails.
Las Vegas-based Skinvisible Pharmaceuticals, (702) 433-7154, has a new antimicrobial lotion to help prevent the spread of methicillin-resistant S. aureus. Skinvisible Skin Sanitizer, formulated with triclosan, has bacteriostatic and/or bacteriocidal properties that are said to be up to 99% effective against a variety of pathogens for up to four hours with each application. The product is available through (877) 925-6000.
Can whiskers stand up and virtually ask to be cut? Gillette Co., Boston, (617) 421-7000, thinks so. A new razor, dubbed the M3Power, comes equipped with a two-blade cartridge and a handle that incorporates a single AAA battery. In use, the razor vibrates rapidly, issuing a buzzing sound that is thought to cause hair shafts to stand up straighter and protrude further from the skin. New blade coatings promise longer life and a smoother shave.
Colorspray Sunless Tan, an airbrush tanning spray, is available in aerosol packaging for a year-round look of health. The formula, which contains aloe and white tea extracts to condition the skin, combines with the body's natural proteins to produce a tan that will last seven to 10 days. It is manufactured by Chase Products, Maywood, Ill., (708) 865-1000.
E-Z-EM, Lake Success, N.Y., has launched a low-volume barium sulfate suspension to ensure accuracy in virtual colonoscopy. Tagitol V, taken with meals, helps reduce false positives and negatives by tagging retained stool for enhanced detection of pathophysiology.
Going beyond ordinary whitening toothpastes, Colgate Simply White combines hydrogen peroxide and a whitening accelerator to remove both surface stains and those embedded below the surface of the teeth. Used twice a day, Simply White can produce whiter teeth in just 14 days, according to its maker, Colgate-Palmolive, New York, N.Y., (212) 310-2000. A 4-oz. dual tube separating the hydrogen peroxide from the whitening accelerator delivers optimum whitening. Sparkling Mint and Spearmint are the flavor choices.
According to Rembrandt Oral Care, a division of Den-Mat Corp., Santa Maria, Calif., (800) 548-3663, a gel masque applied to the teeth at bedtime can deliver a whiter smile in the morning mirror. Rembrandt Nighttime Whitening can be used alone or with a Rembrandt OTC mouthguard bleaching kit.
MINI-LiquiDose labels are available from Medi-Dose Inc./EPS Inc., Ivyland, Pa., (800) 523-8966. Designed primarily for use with syringes and ampules, the labels can accommodate three lines of text with up to 25 characters per line. Or, a complete bar-code line can accompany two lines of text. Labels are equipped with tamper-evident adhesive.
New from Health Care Logistics, Circleville, Ohio, (800) 848-1633, is an elliptical toothbrush with a patented open center that allows water to flow through both the back and the front of the toothbrush, washing away food, saliva, and toothpaste. The Ozone toothbrush is available with ultra-soft, soft-medium, or soft-hard bristles.
For patients with diabetes and other circulatory problems, Zzooties, Bethlehem, Conn., (877) ZZOOTIE, has a line of quarter-cuff stretch-knit socks suitable for bedtime or casual wear. Their Outlast high-tech fiber regulates temperature, while cushioned soles offer shock absorbency.
Nancy Jillard. New Product Newswire. Drug Topics Mar. 22, 2004;148:98.