New Product Newswire

July 1, 2002

Rx Care New Drugs, New Formulation, New Dosing, New Size, New Generics, OTC

 

NEW PRODUCT NEWSWIRE

Rx

NEW DRUGS

Healthpoint Ltd., Fort Worth, (800) 441-8227, is introducing Ovace Wash (sodium sulfacetamide 10%) for treating seborrheic dermatitis of the face. The product offers a nonsteroidal, fragrance-free therapy for use as part of a patient's regular facial cleansing routine. The active ingredient, sodium sulfacetamide, provides a broad spectrum of activity against P. ovale and gram-positive and gram-negative bacteria.

NEW FORMULATION

A new formulation of an existing medication for treating allergies is now available from Laser Inc., Crown Point, Ind., (800) 325-0925. Dallergy-JR. Capsules have been reformulated and now contain the antihistamine chlorpheniramine maleate (4 gm) and the decongestant phenylephrine hydrochloride (20 mg). The product is available in bottles of 100 ... Dallergy Caplets are also available in a new formulation, with 12 mg of chlorpheniramine maleate, 20 mg of phenylephrine hydrochloride, and 2.5 mg of methscopolamine nitrate, an antisecretory. The product is indicated for treatment of allergies.

NEW DOSING

Actonel (risedronate sodium tablets), jointly developed and marketed by Procter & Gamble Pharmaceuticals, Cincinnati, (513) 983-3000, and Aventis Pharmaceuticals, Bridgewater, N.J., (800) 207-8049, is available in a new 35- mg once-a-week tablet. The once-weekly regimen for the bisphosphonate is therapeutically equivalent to the 5-mg daily dosing plan and is indicated for the prevention and treatment of postmenopausal osteoporosis.

NEW SIZE

For treatment of bleeding episodes in hemophilia A or B patients with inhibitors (antibodies) to coagulation Factors VIII or IX, there is NovoSeven Coagulation Factor VIIa (Recombinant) in a new 2.4-mg vial. The drug is already available in 1.2-mg and 4.8-mg vials. According to Novo Nordisk, Princeton, N.J., (800) 727-6500, NovoSeven eliminates the risk of human viral contamination—HIV or hepatitis, for example—because no human albumin or other human-derived proteins are used in the manufacturing process.

NEW GENERICS

Ranbaxy Pharmaceuticals, Princeton, N.J., (609) 720-9200, has final approval from the FDA to manufacture and market cefpodoxime proxetil for oral suspension 50 mg (base)/ 5 ml and 100 mg (base)/5 ml. Available in 50-, 75-, and 100-ml bottles, the suspension is an orally administered extended-spectrum cephalosporin antibiotic that is bioequivalent to Pharmacia's Vantin. It is indicated for mild to moderate infections deriving from susceptible strains of designated microorganisms that cause such conditions as acute otitis media, pharyngitis and/ or tonsillitis, community-acquired pneumonia, and uncomplicated skin and skin structure infections.

Lithium carbonate extended-release tablets, USP, have just been given clearance by the FDA. A product of Barr Laboratories, Pomona, N.Y., (800) BARRLAB, the psychotherapeutic agent offers an alternative to Solvay Pharmaceutical's Lithobid. Indicated in the treatment of manic episodes of manic-depressive illness, the product is available in a 300-mg dosage strength.

Marketing clearance has been granted to Morton Grove Pharmaceuticals, Morton Grove, Ill., (847) 967-5600, for metaproterenol sulfate inhalation solution, USP, 0.4% (10 mg/2.5 ml) and 0.6% (15 mg/2.5 ml). The bronchodilator is indicated for the treatment of bronchial asthma and reversible bronchospasm that may occur in association with bronchitis and emphysema. The medication, available in 2.5-ml unit-dose vials, provides a therapeutic equivalent to Alupent Inhalation Solution, 0.4% and 0.6%, from Boehringer Ingelheim.

From American Pharmaceutical Partners, Los Angeles, (800) 551-7176, comes word of FDA approval for ifosfamide for injection, USP. In combination with certain other approved antineoplastic agents, ifosfamide is indicated for third-line chemotherapy of germ-cell testicular cancer. The drug will be bar-coded at the individual unit-of-use level to increase patient safety ... American Pharmaceutical Partners has also received approval for diphenhydramine hydrochloride injection, USP, in 50 mg/ml strength, 1-ml fill in a 2-ml vial size in a preservative-free formulation for rapid administration. The drug is an antihistaminic indicated for relief of allergic reactions to blood products. As an adjunct to epinephrine in anaphylaxis after control of acute symptoms and for other uncomplicated allergic conditions, the drug provides a generic alternative to Parke-Davis' Benadryl ... And for short-term intravenous treatment of acute low-output heart failure, there is APP's milrinone lactate injection. The cardiovascular product, available in 10-, 20-, and 50-ml vials, offers a generic alternative to Primacor, from Sanofi-Synthelabo. The injection will be bar-coded at the individual unit-of-use level to help reduce medication error.

For treatment and temporary relief of the itching of dry, scaly skin (xerosis) and ichthyosis vulgaris, LAClotion 12% Lotion has been introduced by Paddock Laboratories, Minneapolis, (763) 546-4676. It provides a generic alternative to Westwood-Squibb's Lac-Hydrin (ammonium lactate) 12% Lotion.

Mylan Laboratories, Pittsburgh, (412) 232-0100, has reached an agreement with 3M Pharmaceuticals to launch a Mylan-labeled version of flecainide acetate tablets, a generic alternative to 3M's Tambocor. The antiarrhythmic medication will be available in bottles of 100 in 50-, 100-, and 150-mg strengths. It is indicated for suppression of ventricular arrhythmias ... The company also received FDA approval for levothyroxine sodium tablets USP in strengths of 0.025, 0.05, 0.075, 0.088, 0.1, 0.112, 0.125, 0.15, 0.175, 0.2, and 0.3 mg. The product offers a generic equivalent to Unithroid tablets, from Jerome Stevens, which are indicated for hypothyroidism and the suppression of thyroid-stimulating hormones.

OTC

Schiff, Salt Lake City, (800) 526-6251, a Weider Nutrition International company, is introducing Lutein Supplement Formula for maintaining macular and retinal health. It contains both lutein (5 mg) and zea-xanthin (1 mg), the primary carotenoids found in the retina and the macula and nutrients that can be lost as people age. Zinc (15 mg), beta-carotene (5000 IU of vitamin A), and vitamins C (30 mg) and E (30 IU) supply supporting essential antioxidants. The recommended daily dose is one tablet.

For the sleep-deprived, Well-In-Hand Herbals, Forest, Va., (888) 550-7774, has a new natural way for users to relax, relieve pain, and get a good night's sleep. Sleep Rescue, an herbal blend offering botanical and aroma therapy, can be used as a massage at such tension sites as the forehead, temple, or jaw or in a warm bath to promote relaxation.

For adults and children, Medtech Inc., Norwalk, Conn., (800) 443-4908, has Compound W Waterproof Pads for the treatment of common warts and the often painful plantar warts. There is a regular pad for adults and Garfield character pads for children. According to the company, the extra cushioning of the waterproof pad makes wart removal painless and helps prevent spread of the HPV virus that causes warts.

From PhytoPharmica, Green Bay, Wis., (920) 469-9099, come several new dietary supplements—two for the brain, one for the intestinal tract, and one to help maintain normal cholesterol levels. Mental Acuity Formula is good news for the aging. Its combination of six nutrients offer immediate and long-term support for memory skills and cognitive function. Petadolex Patented Brain Support offers butterbur extract to support brain blood vessel relaxation and circulation. Probiotic Pearls, with active cultures of L. acidophilus and B. longum, were formulated to increase the live bacteria essential to intestinal health. And for working in the liver to inhibit cholesterol production and in the intestines to help impede cholesterol absorption from foods, there is Pantethine Plus, a blend of pantethine (a precursor of coenzyme A) and phytosterols.

Quality of Life Labs, Purchase, N.Y., (914) 251-0981, is now offering Kinoko, for strengthening and maintaining the immune system. Made from a Japanese medicinal mushroom extract, it is available in bottles of 60 500-mg capsules, with a suggested regimen of two to six capsules daily.

Symbiotics Inc., Sedona, Ariz., (928) 203-0277, has come out with two new products. New Life GastroSHIELD is a colostrum supplement to help prevent and repair the gastrointest-inal damage that can be caused by the ingestion of some Rx and OTC medications, foods, food additives, carbonated beverages, and alcohol. And for relieving stress, easing anxiety, and alleviating sleep disorders, there is New Life TryptoZen, a lactose-free supplement based on the milk protein tryptic peptide. According to the company, controlled mental and physical stress tests also indicated a significant reduction in blood pressure in those taking the product.

 

Nancy Jillard. New Product Newswire. Drug Topics 2002;13:69.