NEW PRODUCT NEWSWIRE

Rx

NEW DRUGS

From KV Pharmaceutical Co., St. Louis, (314) 645-6600, comes PrimaCare. The company claims this is the first prescription nutritional supplement with essential fatty acids, which the FDA has now approved for addition to infant formulas to bring them closer to the nutritional superiority of breast milk. PrimaCare is formulated to provide nutritional support prenatally, and postnatally for breastfeeding mothers and their babies, along with ongoing nutritional support for women throughout their childbearing years.

Newly available from IDEC Pharmaceuticals, San Diego, (858) 431-8500, is Zevalin (ibritumomab tiuxetan), used in the treatment of certain B-cell non-Hodgkin's lymphomas. The monoclonal antibody was approved in February. Infused into a patient, the radiation-carrying antibodies locate and bind to the surface of specific cells, then deliver cytotoxic radiation directly to malignant cells.

Doak Dermatologics, Fairfield, N.J., (800) 929-9300, has added another keratolytic formulation to its Carmol 40 line. Carmol 40 (40% Urea) Gel is the company's most potent keratolytic formulation to date. This site-specific tissue softener can be used alone or along with antifungal and steroid therapies as therapy for hyperkeratolytic, diseased, devitalized nails and such skin conditions as corns, calluses, and seborrheic keratoses.

Crinone 8% (progesterone gel), from Serono Inc., Rockland, Mass., (781) 681-2340, has been reintroduced into the U.S. market following an earlier recall involving the viscosity of the product. The progesterone vaginal gel, delivered via a prefilled disposable applicator, is used in the treatment of infertile women needing progesterone supplementation.

Avinza (morphine sulfate extended-release) capsules, from Elan Corp., South San Francisco, (888) 638-7605, have been approved for once-daily treatment of chronic, moderate to severe pain in patients needing round-the-clock pain therapy. The new dual-release formulation contains immediate- and sustained-release morphine beads that provide 24-hour pain relief for many patients with cancer and other medical conditions.

Now available from Savage Laboratories, Melville, N.Y., (631) 454-9071, a division of Altana Inc., is DigiFab (digoxin immune fab [ovine]). The polyclonal antibody product is indicated for the treatment of digoxin toxicity, a potentially life-threatening disturbance of heart function. According to the company, specific antibody fragments bind and neutralize digoxin molecules and facilitate their rapid elimination from the body.

NEW INDICATIONS

Aldara Cream, 5%, from 3M Pharmaceuticals Division, St. Paul, is now indicated for patients age 12 and older. The product is an immune response modifier that induces white blood cells to produce cytokines such as interferon and has been shown to help the body fight the human papillomavirus that causes genital warts. Aldara Cream was previously approved for patients age 18 and older. For ordering information, call (800) 447-4537.

New from Sepracor Inc., Marlborough, Mass., (877) SEPRACOR, comes Xopenex (levalbutol HCl inhalation solution) for the treatment or prevention of bronchospasm in children six to 11 years of age with reversible obstructive airway dis-ease. The beta-agonist will be marketed for use in a nebulizer at dosage strengths of 0.31 mg and 0.63 mg for pediatric patients. The drug has been marketed at 0.63- and 1.25-mg dosage strengths for patients 12 years of age and older.

NEW DISTRIBUTION

Watson Pharmaceuticals, Corona, Calif., (909) 493-5611, has entered into an agreement with Baxter Healthcare Corp., Deerfield, Ill., (847) 948-2000, for the copromotion of Ferrlecit (sodium ferric gluconate complex in sucrose injection) in the U.S. renal market. The intravenous iron-replacement product is indicated for the treatment of iron-deficiency anemia in chronic hemodialysis patients receiving supplemental epoetin therapy.

NEW GENERICS

New from Roxane Laboratories, Columbus, Ohio, (614) 272-4774, is butorphanol tartrate nasal spray CIV, 10 mg/mL, a synthetically derived agonist-antagonist analgesic. In addition to analgesia, CNS effects include depression of spontaneous respiratory activity and cough, stimulation of the emetic center, miosis, and sedation. According to the company, the product is bioequivalent to Bristol-Myers Squibb's Stadol NS Nasal Spray.

Clearing the way for the launch of Gensia Sicor's pamidronate disodium injection is a strategic alliance between Faulding Pharmaceutical, Paramus, N.J., (201) 225-5500, and Gensia parent Sicor Inc., Irvine, Calif., (949) 455-4879. By this agreement, Faulding will waive the 180-day exclusivity it would have on the approval of its ANDA for the agent. Pamidronate is used in the treatment of moderate or severe hypercalcemia associated with malignancy and moderate to severe Paget's disease. Faulding is marketing and distributing the drug.

Barr Laboratories, Pomona, N.Y., (800) BARRLAB, has received FDA approval for its branded generic version of Berlex Laboratories' Levlite tablets oral contracep-tive 28-day regimen. New Lessina will deliver 0.100 mg of levonorgestrel and 0.020 mg of ethinyl estradiol for the prevention of pregnancy.

Available from Eon Labs Manufacturing, Laurelton, N.Y., (800) 526-0225, are 500- and 750-mg nabumetone tablets, offering a generic alternative to Relafen, from GlaxoSmithKline. The nonsteroidal anti-inflammatory drug, which is available in 100- and 500-count bottles, is indicated for acute and chronic treatment of the signs and symptoms of osteoarthritis and rheumatoid arthritis.

Purepac Pharmaceutical, Elizabeth, N.J., (908) 580-5535, has received tentative approval from the FDA to manufacture and market lisinopril in 20-, 30-, and 40-mg tablets. The approval will provide a generic alternative to AstraZeneca's Zestril, an ACE inhibitor indicated for the treatment of hypertension, as adjunctive therapy for the treatment of heart failure, and to improve survival after acute myocardial infarction.

KV Pharmaceutical Co. has received FDA approval for hydrocodone bitartrate and acetaminophen elixir, offering a generic equivalent to Lortab Elixir, from UCB Pharma. The product is a Schedule III narcotic indicated for the relief of moderate to moderately severe pain, with the hydrocodone acting as a narcotic pain reliever and cough suppressant.

Impax Laboratories, Hayward, Calif., (510) 476-2000, has received approval of its ANDA for fludrocortisone acetate tablets, an adrenocortical steroid. The approval provides a generic alternative to Monarch's Florinef, which is used as partial replacement for primary and secondary adrenocortical insufficiency in Addison's disease.

OTC

New OTC clearance has been issued by the FDA for the ReliefBand device from Woodside Biomedical, Carlsbad, Calif., (760) 804-6900. The device, previously available by prescription only, provides drug-free relief of mild to moderate nausea and vomiting associated with pregnancy. ReliefBand, worn on the underside of the wrist, uses electronic signals to generate nerve impulses up to the spinal cord and brain, thus restoring normal stomach operation within minutes.

FutureCeuticals, licensee of Vyrex Corp., La Jolla, Calif., (858) 454-4446, is introducing a chromium supplement called CarnoChrome. The company claims the product has been proven in vitro and in vivo to aid in glucose metabolism, decrease insulin resistance, and help maintain healthy blood cholesterol and triglyceride levels.

According to manufacturer CNS Inc., Eden Prairie, Minn., (800) 441-0417, its new drug-free Breathe Right Snore Relief throat spray can relieve both the nasal breathing difficulties and the loose, vibrating throat tissues of snorers. Natural oils lubricate and soothe the throat, while an astringent tightens loose tissues to reduce vibrations. The product may be used alone or along with Breathe Right nasal strips.

 

Nancy Jillard. New Product Newswire. Drug Topics 2002;8:89.