NEW PRODUCT NEWSWIRE

Rx

NEW DRUGS

Cortic-ND Ear Drops, a product of Everett Labora-tories, West Orange, N.J., (973) 324-0200, is an antiseptic/ antifungal and anti-inflammatory agent incorporating 1 mg chloroxylenol, 10 mg hydrocortisone, 10 mg pramoxine hydrochloride, and 0.10 mg benzalkonium chloride. The product, indicated for the treatment of superficial infections of the external auditory canal, is available in a 15-ml bottle with a plastic dropper.

NEW INDICATIONS

Arimidex (anastrozole), from AstraZeneca, Wilmington, Del., (800) 236-9933, has been cleared for a new indication: adjuvant treatment of hormone receptor-positive early breast cancer in postmenopausal women. Arimidex was approved in 1996 as the first nonsteroidal aromatase inhibitor for treatment of hormone receptor-positive advanced breast cancer in postmenopausal women.

A new indication has been approved for Altocor (lovastatin extended release) for the primary prevention of coronary heart disease in patients without symptomatic cardiovascular disease who have average to moderately elevated total cholesterol and LDL- cholesterol and below-average HDL-cholesterol. Altocor is used to reduce risk of heart attack, unstable angina, and coronary revascularization procedures. The HMG Co-A reductase inhibitor, from Andrx, Fort Lauderdale, Fla., (800) 621-7143, was available already for treatment of patients with coronary heart disease and hyperlipidemia.

GlaxoSmithKline, Research Triangle Park, N.C., (919) 483-2100, has received FDA approval for a new indication for Valtrex (valacyclovir HCl) for the one-day oral treatment of cold sores in healthy adults. The antiviral was approved earlier in once-daily dosing for the suppression of genital herpes outbreaks and as a three-day treatment for recurrent outbreaks of genital herpes.

NEW FORMULATIONS

For Elan Corp., South San Francisco, (888) 638-7605, the FDA has approved a new formulation of the company's currently marketed Zanaflex (tizanidine hydrochloride) tablets. The FDA has cleared the way for 2-, 4-, and 6-mg Zanaflex capsules. Zanaflex is indicated for management of muscle tone associated with spasticity.

NEW DOSAGE STRENGTHS

Approved earlier in 400-mg strength for Elan Corp., Skelaxin (metaxalone) tablets have now been cleared in an 800-mg strength. This offers greater convenience since 800 mg three to four times a day is the recommended dosage. Skelaxin is indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomforts associated with acute, painful musculoskeletal conditions.

Eligard (leuprolide acetate suspension for injection), approved earlier in a 7.5-mg strength that releases drug over a one-month period, is now being launched in a 22.5-mg strength for use over a three-month period. Developed by Atrix Laboratories, Fort Collins, Colo., (970) 482-5868, Eligard is indicated for palliative treatment of prostate cancer. A 30-mg, four-month sustained-release product is under FDA review.

NEW GENERICS

Newly available from TEVA Pharmaceuticals USA, North Wales, Pa., (888) TEVA USA, are cefaclor extended-release tablets in 375- and 500-mg strengths. Cefaclor is a semisynthetic cephalosporin antibiotic indicated for the treatment of acute bacterial exacerbations or secondary bacterial infections of acute bronchitis due to Haemophilus influenzae, Moraxella catarrhalis, or Streptococcus pneumoniae and uncomplicated skin and skin structure infections due to Staphylococcus aureus. This approval offers a generic alternative to Ceclor CD Tablets, a product of Eli Lilly & Co.

Fenofibrate capsules (micronized), in 67-mg strength, have been granted final FDA approval. The lipid-regulating agent, from TEVA, is already available in 134- and 200-mg strengths. The approval provides an AB-rated generic equivalent to Tricor capsules from Abbott Laboratories. Fenofibrate is used in the treatment of high elevations of serum triglyceride levels.

Also approved for TEVA are nizatidine capsules, USP, 150 and 300 mg. The histamine H₂-receptor antagonist provides an alternative to Lilly's Axid. It is indicated for treatment of active duodenal ulcer, maintenance therapy of healed duodenal ulcer, GERD, and benign gastric ulcer.

Ranbaxy Pharmaceuticals, Princeton, N.J., (609) 720-9200, has gained final approval from the FDA to manufacture and market terazosin hydrochloride capsules in 1-, 2-, 5-, and 10-mg strengths. Approval of the alpha₁-selective adrenoceptor blocking agent provides a generic alternative to Hytrin, from Abbott Laboratories. Terazosin is indicated for the treatment of symptomatic benign prostatic hyperplasia. It is indicated also for treating hypertension and can be used alone or in combination with other antihypertensive agents, such as diuretics or beta-adrenergic blocking agents.

Alpharma Inc., Baltimore, (410) 298-1000, has been granted clearance to manufacture and market 2-mg and 4-mg tizanidine hydrochloride tablets, providing a generic alternative to Zanaflex tablets, from Elan Pharmaceuticals. Indicated for the management of spasticity, the product will be marketed under Alpharma's Purepac label.

The FDA has cleared fluoxetine oral solution, USP, 20 mg/5 ml, for Morton Grove Pharmaceuticals, Morton Grove, Ill., (847) 967-5600. Approval of the oral form of this antidepressant provides an alternative to Prozac Liquid, from Lilly. The selective serotonin uptake inhibitor is used in the treatment of depression and obsessive-compulsive disorder.

A generic version of Forest Laboratories' Flumadine (rimantadine hydrochloride) has been approved in 100-mg tablets for Impax Laboratories, Hayward, Calif., (510) 476-2000. Rimantadine, an antiviral drug, is used for the prevention and treatment of illness caused by various strains of influenza A virus in adults.

A 500-mg strength of the nonsteroidal anti-inflammatory drug naproxen sodium has been approved for marketing. The manufacturer, Andrx Corp., also has a 375-mg version of this generic alternative to Elan's Naprelan. The NSAID is used for the treatment of pain caused by arthritis, osteoporosis, and other inflammatory conditions.

The FDA has granted final approval to Barr Laboratories, Pomona, N.Y., (800) BARRLAB, for a generic version of Ortho-McNeil's Ortho-Novum 7/7/7 oral contraceptive. The product includes three different tablet combinations of norethindrone and ethinyl estradiol and is available in 21-tablet and 28-tablet packaging.

Propofol injection emulsion 1% is an intravenous sedative hypnotic agent used in the induction and maintenance of surgical anesthesia and to induce conscious sedation during certain diagnostic procedures. Approval has been granted to Sicor Inc., Irvine, Calif., (949) 455-4879, to market the product in a 100 mg/10 ml single-use vial.

American Pharmaceutical Partners, Los Angeles, (800) 551-7176, which received an earlier approval for ifosfamide for injection, has now launched individually packaged 1-gm vials of ifosfamide. The chemotherapeutic agent, which offers a generic alternative to Bristol-Myers Squibb's Ifex, is usually used in combination with a prophylactic agent for hemorrhagic cystitis (such as mesna) for chemotherapy of germ-cell testicular cancer.

HOSPITAL PRODUCTS

With the prevention of needlesticks critical to a safe working environment, Horizon Medical Products, Atlanta, (404) 264-2600, is offering the LifeGuard Safety Huber infusion set. Infusion sets are used for accessing implantable ports in cancer treatments. In deaccessing a port, the clinician lifts a lever, then pulls the needle into that lever, which traps the needle and protects against a rebound needlestick.

BioMedical Disposal Inc., Norcross, Ga., (770) 300-9595, has received FDA approval for expanding the Sharpx Needle Destruction Unit to include 18- to 30-gauge hypodermic needles. The portable device was originally designed to destroy 19- to 27-gauge needles. The two-pound plastic unit uses a rechargeable 7.2-volt NiCad battery. The current between two electrodes incinerates the needle and casts the debris into one of 12 aluminum-lined debris drawers. The unit, intended for use by healthcare professionals in outpatient and inpatient settings and clinical laboratories, comes with a battery charger.

OTC

Bernardsville, N.J.-based Millennium Biotechnologies, (908) 630-8700, is offering two proprietary products that are reimbursed by managed Medicaid. Resurgex, a blend of nutritional components, targets the chronically ill with compromised immune systems, including loss of lean muscle, nutrient depletion, mitochondrial dysfunction, and oxidative stress. Prosurgex is a powdered formulation in a single-use, disposable container. Mixed with water, the product delivers 400 high-quality calories that can serve as a meal replacement.

For those seeking daytime vitality and rest at night, PhytoPharmica, Green Bay, Wis., (831) 277-5924, has an End Fatigue Energy Revitalizing System with three targeted nutritional formulas. Daily Energy Enfusion, a powdered drink, provides 39 energy-building ingredients, including protein, vitamins, minerals, and amino acids, to support immune, muscle, digestive, and brain health. Daily Energy B Complex has B vitamins and choline for brain health. Revitalizing Sleep Formula blends natural herbs, including L-theanine and extracts of valerian, passionflower, hops, wild lettuce, and Jamaica dogwood root, to promote restful sleep.

The FDA has approved the marketing of Neptune Krill Oil, Neptune Krill Aquatein, and Neptune LyO-Krill as new dietary supplements for human consumption in the United States. These products can be obtained from Neptune Technologies & Bioressources, Montreal, (888) 664-9166.

Home Health Care

Black & Beautiful Inc., Englewood Cliffs, N.J., (877) 811-9709, is adding a new product to its recently launched ethnic skin care line. Multipurpose Black & Beautiful Shea Butter Stick offers a combination of shea butter and vitamin E to soothe skin blemishes and help heal dry, roughened skin.

Deltec Inc., St. Paul, has received clearance from the FDA to market the Deltec Cozmo insulin pump. The small, lightweight device is worn day and night and de- livers insulin continuously through a flexible plastic tube inserted under the skin. The 300-unit insulin cartridge is powered by a single AAA battery. Safety features limit the amount of insulin delivered over the course of an hour and alert the user to a missed meal bolus. For further information, call (651) 628-7248.

Available from Maddak Inc., Pequannock, N.J., (973) 628-7600, are convenient wall-mountable Bath + Safe Swirl Grip grab bars. The bars are 11Ž4 in. in diameter, and they are available in lengths of 12, 16, 18, and 24 in. for a secure, nonslip grasp, even when wet ... Another product enables people to eat an entire meal using only one hand. The Eating Tool eating aid combines the function of both fork and knife.

Disetronic Medical Systems, St. Paul, (800) 280-7801, has launched two new products for patients with diabetes. The PenFine Universal Click Insulin Pen Needles allow patients to click their needles onto any insulin pen instead of threading them on. The needles range from six to 12 mm, and in gauge size from 29G to 31G. The D-TRONplus insulin pump, the only pump, according to the company, to accept Lilly's 300-unit prefilled insulin cartridges, provides a six-day supply of insulin. It comes with a lithium power pack, and its infrared interface allows communication between the pump and a computer. A free backup pump is also provided for use if the original pump needs service.

Health & Beauty Care

Procter & Gamble's Cover Girl, Hunt Valley, Md., (888) COVERGIRL, is thinking holiday season with gold and silver accents for some limited-edition products. Six pairs of basecoats and topcoats make up the Outlast Shimmer Duos for nails. Shimmer Palettes for eyes and lips glow in two combinations: warm and cool. Shimmer Blizzard offers a collection of products for nails, body, and lips.

Women with fine or thinning hair now have a line of daily hair care to turn to: Progaine, from Pharmacia Consumer Healthcare, Bridgewater, N.J., (908) 901-8000. Products to shampoo, cleanse, condition, and style the hair are specially formulated from wheat amino acids and nutrients for a fuller, fat hair look. The products are safe for permed and color-treated hair.

Straight Laced is a new cosmetic line for eyes, lips, cheeks, and nails from L'Oréal, New York City, (212) 818-1500. The line incorporates roses, pinks, and reds with midnight blue to reflect a dramatic interplay of masculine and feminine.

Also from L'Oréal is new Idéal Balance Foundation for women with combination skin. The foundation is formulated to hydrate dry patches and tone down the shiny appearance of oily areas. It is noncomedogenic and offers SPF 10 protection against harmful effects of the sun.

Etc.

Seeking to strengthen its young female consumer base, Panasonic, Secaucus, N.J., has a licensing agreement with Procter & Gamble, Cincinnati, to sell a new line of hair dryers in North America. The new ionic-technology Panasonic Pantene Pro-V hair dryer is designed to condition hair as it dries, locking in moisture for enhanced shine and diminished static. For further information, call (201) 348-7184, or (513) 983-5366.

Virofree, a pocket-size portable disinfectant spray, is available from Biocide Inc., Stamford, Conn., (888) 847-6383. The hospital-strength bacteria- and virus-killing surface disinfectant, known as a quaternary ammonium compound, is formulated to be effective against a broad spectrum of bacteria and viruses but carries a low EPA caution level, according to the company. The 1-oz. spray pump delivers 140 sprays of disinfectant—in restrooms, on airplanes, over shopping cart handles, gym equipment, shared toys, etc.

In wrist-worn and clip-on versions, a new quitting-time watch is available to help with smoking cessation. The Q-T Watch, from ElectroMed Technologies, Chicago, (312) 458-9769, is intended to support long-term reinforcement, making use of computer-tailored motivational messages to help the smoker taper his/her habit, increase the interval between cigarettes, and monitor any accelerated smoking. To order for the pharmacy, go to the Web site www.electromedtechnologies.com and click on "Retail Corner."

Pull-Ups, the disposable training pants, are available in a 30% thinner version than those currently on the market. The gender-specific pants sport designs suitable to boys and girls and come in toddler sizes ranging from 2T through 5T, with gender-customized absorbency panels. The manufacturer is Kimberly-Clark, Neenah, Wis., (888) 558-5061.

Curad, in partnership with the animated family values creation Veggie Tales, is introducing Curad Veggie Tales bandages. Made by Beiersdorf Inc., Norwalk, Conn., (203) 854-8000, the item is targeted toward school age children.

Thomson MICROMEDEX, Greenwood Village, Colo., (800) 525-9083, is launching DISEASEDEX General Medicine, part of the company's healthcare series that helps clinicians identify the best practices for treating diseases through synthesized medical evidence from the latest research. Users of the system can select the level of detail they wish from the summary and in-depth information provided on disease-specific diagnosis and treatment. Also new from Micromedex are illustrations that are being added to the CareNotes patient education system. CareNotes, with its 3,000 customizable documents in both English and Spanish, enhance clinician-patient communication and education with easy-to-understand information on the care and health of patients with medical conditions.

Can you do a stand-up job with only a third of your weight on your feet? The Kango Stand-up Seat, from Health Care Logistics, Circleville, Ohio, (800) 848-1633, takes much of the fatigue and poor posture out of standing and leaning. The cushioned seat adapts to the user's body shape to allow continuous blood flow without affecting leg circulation. It keeps the back straight, allows the legs to stretch, and is height-adjustable.

For attacking tough cleanup jobs on pots, pans, and dishes, there's Palmolive Super Scrub Gel Paste, new from Colgate-Palmolive Co., New York City, (212) 310-2000. Squeezed onto a sponge, its "crystal blue scrubbers" purportedly remove stuck-on, baked-on foods with ease.

A newer version of a high-protein, low-fat snack is now available in Pemmican Long Lasting Style Beef Jerky, from ConAgra Foods, Omaha, (402) 595-4000. Thin strips of beef round are marinated in a blend of flavors and spices for 48 hours, cooked slowly, naturally smoked, and dried into a curled shape to provide consumers with the more traditional, drier type of beef jerky.

 

Nancy Jillard. New Product Newswire. Drug Topics 2002;19:99.