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Cell Pathways Inc., Horsham, Pa., (215) 706-3800, has signed an agreement with British firm Sinclair Pharma Ltd. to become the exclusive North American distributor of Gelclair Concentrated Oral Gel. The company plans to promote the product initially in the oncology market. The clear viscous gel, applied by rinsing the mouth, adheres to the mucosal surface of the mouth, where it soothes oral lesions of various etiologies. The FDA has granted clearance for the marketing of Gelclair for use in the management and relief of pain from oral mucositis/stomatitis, as well as irritation from oral surgery and traumatic ulcers caused by braces or ill-fitting dentures or disease.
Kos Pharmaceuticals, Miami, (305) 512-7000, is now launching Advicor. The drug is a combination of Kos' extended-release niacin (Niaspan) and lovastatin for treatment of primary hypercholesterolemia and mixed dyslipidemia in patients previously treated with either component of the product and who require additional lipid modification for LDL or HDL cholesterol and triglycerides beyond that achieved by the individual components. The drug was approved in strengths of 500 mg/20 mg, 750 mg/20 mg, and 1000 mg/20 mg.
Now approved for life-threatening gastrointestinal cancer is Novartis' Gleevec (imatinib mesylate). Gleevec was approved in 2001 as a treatment for chronic myeloid leukemia. The FDA has now cleared the drug as a treatment for metastatic malignant gastrointestinal stromal tumors (GISTs), offering the first nonsurgical option in the treatment of that disease. East Hanover, N.J.-based Novartis can be reached at (973) 781-8300.
To Bristol-Myers Squibb, Princeton, N.J., (800) 426-7644, the FDA has given its approval for a new one-tablet 600-mg formulation of Sustiva (efavirenz). The one-tablet dosing will help HIV/ AIDS patients be more compliant in their drug regimen. The non-nucleoside reverse transcriptase inhibitor is used in combination with other antiretroviral drugs for the treatment of HIV. Previously, the dosage was available only as three 200-mg capsules. The new tablet is approximately the same size as one 200-mg capsule.
Sepracor, Marlborough, Mass., (508) 481-6700, has received FDA approval for Xopenex (levalbuterol HCl inhalation solution) for treatment or prevention of bronchospasm in children six to 11 years of age with reversible obstructive airway disease. Xopenex will be marketed for use in a nebulizer at dosage strengths of 0.31 mg and 0.63 mg for pediatric patients. The product has been available at dosage strengths of 0.63 mg and 1.25 mg for patients 12 years of age and older since May 1999.
King Pharmaceuticals, Bristol, Tenn., (423) 989-8000, is releasing Tigan (trimethobenzamide hydrochloride) 300-mg capsules. The product is indicated for the treatment of postoperative nausea and vomiting and for nausea associated with gastroenteritis. Tigan capsules were already available in 100- and 250-mg strengths.
Norcross, Ga.-based SpectRx Inc., (770) 242-8723, has FDA clearance to market a new, minimally invasive insulin infusion patch set that is compatible with the three major insulin pump brands. Pumps are programmed to provide insulin into the tube of the infusion set, which then delivers a steady stream of insulin through five microneedles that are less than half the length of ordinary insulin pump infusion needles.
GlaxoSmithKline, Research Triangle Park, N.C., (919) 483-2100, has repackaged its antimalarial, Malarone (atovaquone and proguanil hydrochloride), into blisterpacks of 24 tablets for easier dispensing by the pharmacist. The drug is approved for malaria prevention.
Levsinex Timecaps (hyoscyamine sulfate 0.375 mg) Extended-Release Capsules, from Schwarz Pharma, are now supplied in brown and white capsules (the capsules were previously brown and clear). The drug is used as an adjunctive therapy in the treatment of peptic ulcer. In addition, the dye has been removed from Levsin/SL Tablets (hyoscyamine sulfate tablets, USP), and the tablets are now white.
Generic manufacturers are now beneficiaries of the FDA's approval of generic versions of metformin, providing a more affordable alternative to Bristol-Myers Squibb's Glucophage. Metformin is an oral antiglycemic drug used in the management of Type 2 diabetes. TEVA USA, North Wales, Pa., (888) TEVA USA, and Par Pharmaceuticals (marketing Genpharm's version), Spring Valley, N.Y., (845) 425-7100, are introducing metformin hydrochloride tablets in 500-mg and 850-mg strengths. Bringing out strengths of 500, 850, and 1000 mg are the following firms: Alpharma's Purepac division, Elizabeth, N.J., (908) 527-9100; Andrx Pharmaceuticals, Ft. Lauderdale, Fla., (800) 621-7143; Barr Laborator- ies, Pomona, N.Y., (800) BARRLAB; Eon Labs, Laurelton, N.Y., (800) 526-0025; Pharmaceutical Resour- ces, Spring Valley, N.Y., (845) 425-7100; and Watson Pharmaceuticals, Corona, Calif., (909) 493-5611. IVAX Corp., Miami, (305) 575-4105, will provide the tablets in strengths of 500, 625, 750, 850, and 1000 mg.
FDA approval has been granted to Paddock Laboratories, Minneapolis, (800) 328-5113, for Podofilox Topical Solution 0.5%, with Accutip Wand applicator. The product, indicated for the topical treatment of external genital warts (Condyloma acuminatum), offers a generic alternative to Condylox Solution, from Oclassen Pharmaceuticals. Podofilox is contraindicated for patients who develop hypersensitivity or intolerance to any component of the formulation. The solution is available in a 3.5-ml bottle with 24 Accutip Wand applicators.
G&W Laboratories has been given the FDA nod for 25-mg promethazine HCl suppositories for treatment of nausea and vomiting. The product, therapeutically equivalent to Wyeth-Ayerst's Phenergan suppositories, complements G&W's Promethegan 50-mg suppository. The South Plainfield, N.J., firm can be reached at (800) 922-1038.
Alpharma, Baltimore, (410) 298-1000, has received approval for methylphenidate hydrochloride tablets, providing a generic equivalent for Ritalin tablets, from Novartis. The drug is indicated in the treatment of attention deficit disorder and narcolepsy.... The company's Purepac division has received final approval for diclofenac sodium extended-release tablets, 100 mg, a generic equivalent to Voltaren-XR, from Novartis. It is indicated for chronic therapy of osteoarthritis and rheumatoid arthritis.
Able Laboratories, Cincinnati, (888) 826-ABLE, has FDA permission for 75-mg indomethacin extended- release capsules, USP, a therapeutic equivalent to Eon Labs' Indocin SR capsules. A nonsteroidal drug with anti-inflammatory, antipyretic, and analgesic properties, it is indicated in the treatment of rheumatoid arthritis, ankylosing spondylitis, osteoarthritis, and acute painful shoulder.
Ranbaxy Pharmaceuticals, Princeton, N.J., (609) 720-9200, has received tentative approval for loratadine 10-mg tablets, providing a generic equivalent to Schering's Claritin, a long-acting tricyclic antihistamine. Loratadine is indicated for relief of nasal and non-nasal symptoms of seasonal allergic rhinitis and for treatment of chronic idiopathic urticaria in patients six years of age and older.
Now available from Barr Laboratories is dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, amphetamine sulfate tablets, 5 mg, 10 mg, 20 mg, and 30 mg. These mixed salts of a single-entity amphetamine product provide a generic equivalent of Adderall tablets, from Shire Richwood. The product is indicated as part of a total treatment program in children with behavioral syndrome including, among other characteristics, short attention span, hyperactivity, and impulsivity.
Several companies also have approval for fluoxetine hydrochloride, the generic equivalent to Eli Lilly's Prozac, an antidepressant. IVAX Corp.; Watson Pharmaceuticals; Mylan Laboratories, Pittsburgh, (412) 232-0100; and United Research Laboratories/Mu-tual Pharmaceutical Co., Philadelphia, (215) 288-6500, have been cleared to market fluoxetine hydrochloride capsules, 10 and 20 mg, for the treatment of depression and obsessive-compulsive disorder (OCD). TEVA USA has permission to market fluoxetine HCl capsules in 10-, 20-, and 40-mg strengths and fluoxetine HCl tablets in 10-mg strength; Barr Laboratories is cleared for fluoxetine HCl tablets in 10-mg strength. To Alpharma, permission has been granted for fluoxetine HCl oral solution for treating depression, OCD, and bulimia nervosa.
For Fougera, Melville, N.Y., (800) 645-9833, a division of Altana Inc., the FDA has approved the marketing of clindamycin phosphate lotion (clindamycin phosphate topical suspension USP, 1%). The topical antibiotic product is AB-rated to Cleocin T, from Pharmacia. Available in 60-ml bottles, it is indicated for the topical treatment of acne vulgaris.
Mylan Laboratories has secured FDA approval for mirtazapine tablets, 15-, 30-, and 45-mg. The product, indicated for the treatment of depression, is the generic version of Organon's Remeron.
The FDA has granted its approval to Schwarz Pharma, Mequon, Wis., (800) 558-5114, for isosorbide mononitrate extended-release tablets. The vasodilating drug, available in strengths of 30-, 60-, or 120-mg, is indicated for the prevention of angina pectoris due to coronary artery disease.
From American Pharmaceutical Partners, Los Angeles, (800) 551-7176, comes newly approved ketorolac tromethamine injection, USP, in 15-, 30-, and 60-mg single-dose vials. This approval provides a generic version of Hoffmann-La Roche's NSAID Toradol, indicated for relief of moderately severe pain.
A new protectant and treatment for canker sores is available in Colgate Orabase Soothe-n-Seal. A liquid bioadhesive technology provides an oral "bandage" over the sore, preventing further irritation while the wound heals. The product, which is tasteless, odorless, and alcohol free, provides pain relief for up to six hours. It is available from Colgate Oral Pharmaceuticals, Canton, Mass., (800) 962-2345.
For men who cannot tolerate the side effects of popu-lar impotence medications, Male Virility offers a natural alternative. It is available from Neurochemical Research Corp., San Luis Obispo, Calif., (805) 543-9185, a marketer of dietary supplements for specific conditions.
Claiming a breakthrough treatment for ear wax, Earest Inc., Columbia, Mo., (877) 874-3929, offers the surgeon-invented Ototek Loop. It provides the consumer with a safe way to remove ear wax at home. A disk-like guard prevents the looped tip, modeled after the physician's ear curette, from reaching or potentially damaging the eardrum.
A new lotion from Combe Inc., White Plains, N.Y., (914) 694-5454, is formulated to soothe and protect dry, itchy, chapped skin all over and year-round. Medicated with dimethicone and containing vitamins C, E, A, and D, Lanacane Medicated Body Lotion helps protect skin from chafing, chapping, and cracking. The product is available in a 6-oz. bottle.
Kroger pharmacies nationwide will now be selling DHA GOLD dietary supplements for pregnant and lactating women. New from OmegaTech Inc., Boulder, Colo., (303) 381-6238, the products incorporate docosahexaenoic acid (DHA), a long-chain omega-3 fatty acid, said to be critically important to a developing fetus and during the first years of a baby's life.
For postsurgical patients, Health Care Logistics, Circleville, Ohio, (800) 848-1633, has a pain management pillow that can be applied with gentle pressure against an incision area to provide support and lessen the sting if a patient coughs or moves. The pillow, made of ensolite foam, comes with one disposable pillow cover; additional covers are available.
MedGen Inc., Boca Raton, Fla., (561) 750-1100, maker of ComfortCare anatomy-specific products, has FDA clearance to market a new magnetic insole. Made of Absortek, a fabric that absorbs and vents perspiration to keep feet dry and less open to bacterial growth and odor, the insoles can be inserted into sport, casual, and dress footware for relief of minor physical discomfort due to injuries, stress, and strain from repetitive actions.
From Beiersdorf USA, Wilton, Conn., (203) 854-8000, comes the Curad Travel First Aid Kit. The portable kit houses 30 first aid items, including adhesive bandages, tweezers, burn ointment, motion sickness tablets, gauze, and alcohol swabs, and is compact enough for storage in glove compartments, backpacks, and diaper bags. Priced at $4.99, the item is certified by the American Safety & Health Institute.
Kernco Instruments Co., El Paso, (915) 852-3375, is introducing a group of new refractometers with FDA clearance. Model SP-D measures serum protein; Model AR200 measures urine specific gravity, total serum protein, and refractive index; Model PU-ATC measures serum protein, urine specific gravity, and refractive index; No. 11F23 measures urine-specific gravity and temperature as well as serum total protein and temperature.
An antimicrobial fabric with natural mineral content is now available from Torrance, Calif.-based Pi-ray America Inc., (310) 533-7099. The use of this textile product in linens, blankets, pillow-cases, uniforms, and gowns could reduce incidence of cross-contamination and nosocomial infections in healthcare facilities, according to the company.
Nancy Jillard. New Product Newswire. Drug Topics 2002;5:96.