NEW PRODUCT NEWSWIRE

Rx

NEW DRUGS

Lewiston, N.Y.-based LAM Pharmaceutical Corp., (877) LAM 7717, is offering a newly approved wound care product: L.A.M. IPM Wound Gel. Its principal ingredient is hyaluronic acid, a molecule found in skin, joints, and bones. It is nonimmunogenic and is involved in such biological functions as tissue hydration and the formation of proteins and sugars to optimize tissue repair and prevent tissue aging. The clear, odorless gel is approved for diabetic ulcers, venous stasis ulcers, pressure ulcers, and debrided wounds, where a moist environment helps support the healing process.

Vfend (voriconazole), from Pfizer Inc., New York City, (800) 438-1985, has been granted FDA approval. The new medication, available in 50- and 200-mg tablet and 200-mg injection formulations, is indicated for the treatment of invasive aspergillosis and serious fungal infections. The intravenous approval includes the use of CyDex Inc.'s proprietary Captisol-Enabled drug delivery, which supports the safe, effective delivery of medications by improving the solubility, stability, and bioavailability of drug compounds.

NEW INDICATIONS

For the benefit of those patients with moderately to severely active Crohn's disease, Remicade (infliximab) has been approved for inducing and maintaining clinical remission of the debilitating symptoms of the disease. The approval, granted to Centocor Inc., Malvern, Pa., (610) 651-6000, was based on 54-week data from the ACCENT I trial, which treated 545 patients with 5 mg/kg infusions of the monoclonal antibody at varying intervals. Remicade was approved earlier for fistulizing Crohn's disease and for treatment of rheumatoid arthritis.

Nastech Pharmaceutical Co., Bothell, Wash., (425) 908-3600, will issue new FDA-approved labeling for an expanded indication for Nascobal (cyanocobalamin, USP). The product can now be used in patients with HIV, AIDS, multiple sclerosis, and Crohn's disease. The nasally administered drug is indicated to maintain therapeutic levels of vitamin B₁₂ in patients whose disease has resulted in vitamin B₁₂ deficiency. Nascobal was approved in 1996 for maintenance of the hematologic status of patients in remission following intramuscular vitamin B₁₂ therapy and has been marketed by Schwarz Pharma.

NEW FORMULATIONS

Schering-Plough, Kenilworth, N.J., (908) 298-4000, has acquired approval for Clarinex Reditabs 5 mg (desloratadine) for the treatment of allergy symptoms caused by perennial indoor and seasonal outdoor allergens and chronic idiopathic urticaria in adults and children age 12 and older. The nonsedating, rapidly disintegrating antihistaminic follows Clarinex 5-mg tablets as the second formulation of Clarinex to be approved by the FDA.

A lower-dose formulation of Retin-A Micro (tretinoin gel) microsphere has been approved for its maker, Ortho Neutrogena, Los Angeles, (800) 217-1136. Retin-A Micro 0.04% is a topical treatment for acne vulgaris that in clinical studies significantly reduced noninflammatory and inflammatory acne lesions with a high level of tolerability, with results observed as early as two weeks.

NEW DOSAGE STRENGTH

The FDA has approved a new 250-mg dosage formulation of Depakote ER (divalproex sodium, extended-release tablets), from Abbott Laboratories, Abbott Park, Ill., (800) 255-5162. A 500-mg strength of Depakote ER was approved in 2000. The drug is indicated for the prevention of migraine headaches.

NEW PACKAGE SIZE

A new 30-gm plastic squeeze bottle of Nystop (Ny-statin Topical Powder, USP) is now available from Paddock Laboratories, Minneapolis, (800) 328-4676. Nystop, an antifungal antibiotic, is indicated for the treatment of cutaneous or mucocutaneous mycotic infections caused by Candida (Monilia) albicans and other susceptible Candida species. The powder is applied to Candidal lesions two to three times a day. Relief of symptoms generally follows within 24 to 72 hours. Nystop is also available in a 15-gm bottle.

NEW GENERICS

For the treatment of attention deficit hyperactivity disorder (ADHD), approval has been given to Eon Labs, Laurelton, N.Y., (718) 276-8607, for dextroamphetamine and amphetamine mixed salts. The approval provides a generic alternative to Adderall, from Shire Richwood.

Morton Grove Pharmaceuticals, Morton Grove, Ill., (847) 967-5600, has FDA marketing clearance for prednisolone sodium phosphate oral solution 5 mg (base)/5 ml. The medication is an adrenocortical steroid indicated for the treatment of conditions associated with disorders and diseases of many organ systems. It offers a therapeutic equivalent to Celltech Pharmaceuticals' Pediapred Oral Solution, 5 mg (base)/5 ml.

Fluoxetine oral solution, 20 mg/5 ml, a generic equivalent of Eli Lilly's Prozac Oral Solution, has been approved for Hi-Tech Pharmacal Co., Amityville, N.Y., (631) 789-8228. Fluoxetine is indicated for the treatment of depression.

Barr Laboratories, Pomona, N.Y., (800) BARRLAB, has FDA clearance to manufacture and market a generic version of Wyeth's Nordette Tablets. Barr will market the 28-day oral contraceptive (0.15 mg levonorgestrel and 0.03 mg ethinyl estradiol) under the brand name of Portia.

The FDA has given approval to two companies for tramadol hydrochloride tablets, 50 mg. Permission to market is now held by Able Laboratories, Cincinnati, (888) 826-ABLE, and Eon Labs. Able will manufacture and supply its version under the IVAX Corp. label. Tramadol, a generic alternative to Ultram, from Ortho-McNeil Pharmaceutical, is a centrally acting synthetic analgesic indicated for the treatment of pain.

Four companies have garnered ANDA approval for tizanidine hydrochloride tablets, a generic alternative to Elan's Zanaflex. Elan Pharmaceuticals, South San Francisco, (888) 638-7605, and Eon Labs will market a 4-mg strength of the drug. Par Pharmaceutical, Spring Valley, N.Y., (845) 425-7100, through an agreement with Dr. Reddy's Laboratories, developer of the product, will dis- tribute 2-mg and 4-mg strengths of the tablet, as will TEVA Pharmaceuticals, North Wales, Pa., (888) TEVA USA. Tizanidine, a centrally acting alpha-2 adrenergic agonist, is indicated in the management of spasticity.

Lisinopril tablets USP, a generic alternative to Zestril tablets or Zestoretic, from AstraZeneca, have been approved in strengths of 2.5, 5, 10, 20, 30, and 40 mg for Eon Labs; IVAX Corp., Miami, (305) 575-6215; Mylan Laboratories, Pittsburgh, (412) 232-0100; Ranbaxy Pharmaceuticals, Princeton, N.J., (609) 720-5615; TEVA Pharmaceuticals, North Wales, Pa.; and Watson Pharmaceuticals, Corona, Calif., (909) 493-5611. Lisinopril/HCTZ tablets, in strengths of 10 mg/12.5 mg, 20 mg/12.5 mg, and 20 mg/25 mg, have been cleared for Eon Labs, IVAX, Ranbaxy, TEVA, and Watson, as well as for Alpharma Inc., Fort Lee, N.J., (201) 228-5085. The combination drug provides an alternative to Merck's Prinivil or Prinizide. Lisinopril and lisiniprol/HCTZ are both indicated for the treatment of hypertension, heart failure, and acute myocardial infarction.

Eon Labs, IVAX Corp., Mylan Laboratories, Par Pharmaceutical, and Watson Pharmaceuticals have FDA approval for nizatidine capsules, USP, providing a generic alternative for Axid, from Reliant Pharmaceuticals. The approvals are for 150- and 300-mg strengths of the H₂ antagonist, which is indicated for the treatment of heartburn, acid indigestion, active duodenal ulcers, and esophagitis.

OTC

AdvantEdge Carb Control Nutrition Bar, from EAS, Golden, Colo., (800) 2977-9776, is offered in two new flavors: chocolate chip brownie and chocolate peanut butter. These between-meal snacks provide 25 gm of protein and 26 essential vitamins and minerals.

Combe Inc., White Plains, N.Y., (800) 431-2610, has made several enhancements to its line of Vagisil feminine care products. Vagisil Foaming Wash has been renamed Vagisil Cleansing Foam to clarify its use as a feminine wash. Skin-conditioning agents, along with vitamins A, D, E, and Panthenol (pro vitamin B), have been added, and a new hypollergenic scent, Summer Breeze, will replace the hypoallergenic, fragrance-free version. Vagisil Deodorant Powder has superseded Vagisil Feminine Powder to highlight its deodorant protection. It can be used daily on the entire body after bath or shower. Vagisil Intimate Lubricant, formerly Vagisil Intimate Moisturizer, is a nonhormonal, pH-balanced, vitamin E-enriched lotion for instant relief from vaginal dryness.

A line of 14 Indian herbs has been relaunched by Himalaya USA, Houston, (800) 869-4640. The Pure Herbs products, from Amla to Triphala, are manufactured and, for the most part, grown by the Himalaya Drug company, combining modern pharmaceutical technology with an old system of natural medicine.

Wyeth Consumer Healthcare, Madison, N.J., (973) 660-6923, is targeting energy-minded consumers with its new Centrum Performance Energy Nutrition Bar. A complement to Centrum Performance multivitamins, it combines carbohydrates and protein with vitamins and minerals to help sustain an active lifestyle.

A product launch is imminent for LipoBloc and LipoLette, two proprietary dietary formulations from AlphaRx Inc., Richmond Hill, Ontario, (905) 762-0745. LipoBloc, a phytosterol product, offers consumers a means to help reduce high cholesterol levels. LipoLette supports weight control by working to decrease the accumulation of fat in the body without the side effects of insomnia and agitation.

Home Health Care

Mark of Fitness, Shrewsbury, N.J., (732) 842-7200, a subsidiary of NISSEI of Japan, offers private-label home blood pressure monitors. The monitors include upper-arm manual-inflate units, upper-arm autoinflation units, wrist units, and finger units. The company claims the devices not only take blood pressure and pulse quickly and accurately but also offer a variety of memory options for storing results.

Becton-Dickinson, Franklin Lakes, N.J., launched the Integra Syringe with Retracting Precision Glide needle developed by Med-Design Corp., Ventura, Calif. This safety needle was designed to enable medical workers to perform a wide range of medical procedures at greatly reduced risk of accidental needlesticks. Integra is primarily a hospital product, with no outpatient application at this time. It can be ordered through B-D distributors. For information, call (888) 237-2762.

Etc.

Provectus Pharmaceuticals, Knoxville, Tenn., (865) 769-4012, through Hope Health Care Supply, will be distributing its GloveAid and Pure-ific instant sanitizer products. GloveAid helps make disposable gloves more comfortable to wear by reducing perspiration and preventing the growth of bacteria in warm, wet conditions. The Puri-fic product line offers antibacterial spray products that can kill up to 99.9% of germs on the skin and inhibit their regrowth for up to six hours.

Health Care Logistics, Circleville, Ohio, (800) 848-1633, offers new Chemotherapy Training Kits for pharmacy and oncology healthcare providers. A training and certification program provides participants with hands-on training in the techniques for safe handling of chemotherapy drugs. Twelve contact hours toward certification are awarded after completion of the pharmacy program ... The company has available a polypropylene pocket tablet case with cutter, for keeping medication organized. One compartment holds two small pillboxes and the other a tablet cutter with stainless steel blades ... A new first aid kit organizes supplies into compartment trays, with translucent lids for quick identification. A hanging bracket permits mounting on walls or inside vehicles ... And a locking refrigerator keeps medications secured in the Pyxis Remote Manager. The refrigerator has an automatic defrost, interior light, removable shelves, storage bins with covers, and is set on two rear rollers for easy moving.

Roberts Book Holder, from Maddak Inc., Pequannock, N.J., (973) 628-7600, offers a convenient method of reading hands-free. It will accommodate a variety of sizes of books or magazines at a comfortable angle, and adjustable pegs keep pages from flipping. It can also serve as a computer text aid. The item folds flat for storage ... Also from Maddak, the Pockets educational tool offers visual, repetitive, hands-on learning skills for reading, writing, and general communication. It helps children with autism, attention deficit disorder, or language delays understand the concepts of colors, numbers, and shapes.

Abbott Laboratories' Ross Products division, Columbus, Ohio, (800) 986-8510, has launched Similac Advance with Iron, an iron-fortified infant formula supplemented with DHA and ARA oils. Addition of these fatty acids to infant formula is believed to provide nutrition that more closely emulates breast milk and significantly improves the mental and visual development of formula-fed babies. According to the company, the formula has also been shown to provide greater calcium absorption and greater bone density than other formulas.

An "interdental toothbrush" is now available in the form of periodontal floss from Thornton International, Norwalk, Conn., (800) 445-3567. A clinical study has demonstrated significant reduction in gingival inflammation and tooth plaque within five weeks of use of this new "bushy" dental floss.

 

New Product Newswire. Drug Topics 2002;15:104.