MGI Pharma, Minneapolis, (800) 562-5580, has begun promoting Hexalen capsules (altretamine) and Mylocel tablets (hydroxyurea) in the U.S. oncology market. MGI Pharma purchased the exclusive worldwide rights to Hexalen capsules from MedImmune in November 2000 and was selected by Barr Laboratories to be the exclusive marketer of Mylocel tablets in January 2001. Hexalen is an orally administered second-line chemotherapeutic agent for the treatment of ovarian cancer in patients with persistent or recurrent disease following first-line therapy with cisplatin and/or alkylating agent-based combination chemotherapy. Mylocel, an antineoplastic agent, is indicated for the treatment of melanoma; resistant chronic myelocytic leukemia (CML); and recurrent, metastatic, or inoperable carcinoma of the ovary. It is also indicated for use in combination with radiation therapy for certain head and neck cancers. Recently approved by the FDA, Mylocel is the only triple-scored, 1,000-mg hydroxyurea tablet available, offering simplified dosing in 250-mg increments and the possibility of once-daily dosing with a single tablet.
Protonix I.V. for injection has been approved by the FDA for short-term treatment (seven to 10 days) of gastroesophageal reflux disease (GERD) as an alternative to oral therapy in hospitalized patients unable to continue taking Protonix (pantoprazole sodium) delayed-release tablets. The approval makes Protonix the first proton pump inhibitor (PPI) available in the United States in both oral and intravenous formulations. The safety and efficacy of Protonix intravenous formulation as an initial treatment for GERD have not been demonstrated. Treatment with Protonix I.V. should be discontinued as soon as the patient can be treated with Protonix delayed-release tablets. Protonix will be marketed by Wyeth-Ayerst Laboratories, Radnor, Pa., (800) 666-7248, the pharmaceutical division of American Home Products. Protonix I.V. must be used with an in-line filter, and the appropriate filters will be supplied with each box.
Merz Pharmaceuticals, Greensboro, N.C., (888) MERZ-USA, introduced Naftin-MP 60 gm (naftifine hydrochloride) 1% cream, the first multipack topical antifungal, to its line of Naftin products. The multipack's four 15-gm tubes afford patients the option of a convenient travel size of the medication. Naftin 1% is the only prescription allylamine to be offered in both cream and quick-drying gel. It is indicated for the topical treatment of tinea pedis, tinea cruris, and tinea corporis.
The FDA approved a new formulation of Tripedia, from Aventis Pasteur, Swiftwater, Pa., (570) 839-7187. The new formulation has no preservatives and only a trace amount of thimerosal, a stabilizer that contains mercury. Tripedia is a vaccine used to inoculate children against diphtheria, tetanus, and pertussis. The new Tripedia has less than 0.5 mcg of mercury per dose, which reflects a greater than 95% reduction in the amount of thimerosal per dose over the original Tripedia.
Barr Laboratories, Pomona, N.Y., (845) 348-6808, received FDA approval to manufacture and market generic versions of Ortho-McNeil Pharmaceutical's Ortho-Novum 1/35 tablets and Modicon-28 tablets. The company plans to market both oral contraceptives as branded generics using the Nortrel trademark. Ortho-Novum 1/35 contains 1 mg of norethindrone and 0.035 mg of ethinyl estradiol. The product is supplied in 21-day and 28-day regimens. Modicon-28 contains 0.5 mg of norethindrone and 0.035 mg of ethinyl estradiol. The product is supplied in 21-day and 28-day regimens; Barr plans to launch the 28-day regimen.
The FDA also approved Barr Laboratories' proprietary methotrexate tablets USP in 5-mg, 7.5-mg, 10-mg, and 15-mg strengths. The product will be marketed under the Trexall brand name by DuPont Pharmaceuticals, under the terms of a product marketing agreement finalized last year. Trexall offers new dosage strengths of an antimetabolite used in the treatment of certain neoplastic diseases, severe psoriasis, and adult rheumatoid arthritis. According to company information, prior to Trexall's approval, methotrexate tablets were available only in the 2.5-mg tablet strength. Trexall will afford physicians the option of prescribing higher dosage strengths utilizing scored tablets. Barr's application for its proprietary versions used Lederle Laboratories' Rheumatrex 2.5-mg tablet as the reference drug.
TEVA Pharmaceuticals has rolled out etodolac extended-release tablets, 400 mg. Indicated for treating the symptoms of osteoarthritis and rheumatoid arthritis, the drug is AB rated and bioequivalent to American Home Products' Lodine XL. The North Wales, Pa., firm, (888) TEVA-USA, already produces a 500-mg and 600-mg version of the drug.
Pharmaceutical Resources, Spring Valley, N.Y., (845) 425-7100, recently announced that Par Pharmaceuticals, a wholly owned subsidiary, has received tentative approval from the FDA for its Abbreviated New Drug Application for buspirone 7.5-mg tablets. Buspirone is indicated for the treatment of anxiety disorder.
From Merz Pharmaceuticals, Greensboro, N.C., (888) MERZ-USA, come several new products added to its skin-care line. AquaGlycolic is an alpha hydroxy acid-based skin-care system that has a high glycolic acid content but is pH balanced. It consists of six products: hand & body lotion, facial cleanser, body scrub, shampoo & body wash, astringent, and face cream.
A nutritionally balanced, all-natural meal-replacement shake mix has been introduced by Naturade Inc., Irvine, Calif., (800) 421-1830. New Naturade Total Soy PLUS is made from certified, non-genetically modified soybeans and guarantees a minimum of 58 mg of naturally occurring soy isoflavones in each serving, with no fortification or synthetic ipriflavones. One shake provides 25 gm of soy protein and 100% of the daily value of 19 vitamins and minerals. The product can be mixed with water or milk and is offered in two flavors: Dutch chocolate and creamy vanilla. The suggested retail price is $15.95 for a 12.7-oz. container.
Nutrition 21, Purchase, N.Y., (914) 701-4500, is introducing Diachrome, the first of the company's second generation of chromium picolinate-based ingredients. The patented formulation, which combines chromium picolinate and biotin, works synergistically to improve glucose uptake and lipid profiles for consumers predisposed to diabetes.
Two new forms of Schiff's Move Free glucosamine/chondroitin joint care supplements are now available. Schiff, Salt Lake City, (800) 526-6251, is offering its glucosamine/chondroitin blend in easy-to-swallow gelcaps and in apple-cinnamon and chocolate crunch-flavored bars ... The company is also introducing Soy One nutritional bars. Each bar contains 15 gm of soy protein, 100% of the recommended daily allowance of 15 vitamins, six gm of fat, 40 gm of carbohydrates, and two gm of dietary fiber. The bars come in two flavors: chocolate raspberry and apple cinnamon.
Functional Foods, Belmont, Mass., (617) 932-1700, is offering a new beverage/tablet combination made with a proprietary blend of supplements. Designed to be taken twice a day, with lunch and dinner, Level Best is intended to help improve blood sugar and blood lipid levels in patients with diabetes. The product includes several nutrients that have been clinically shown to manage fasting blood glucose levels, including fiber from psyllium and fructose and barley. Level Best also contains red yeast rice to help manage healthy blood lipids and willow bark to augment the body's natural blood clotting system.
Advil 165-count tablets, caplets, and gel caplets, from Whitehall-Robins, Madison, N.J., (973) 660-5500, are now available with a new arthritis-friendly cap. The cap has been commended by the Arthritis Foundation for improving acces-sibility and enhancing ease of use for arthritis sufferers.
Novartis Consumer Health, Summit, N.J., (908) 598-7624, has been granted FDA approval for Tavist Allergy/Sinus/Headache for marketing over the counter. This product is the only OTC medication to combine the antihistamine clemastine fumarate with a nasal decongestant and pain reliever. It is indicated for treatment of allergies; sinus congestion and pressure; runny nose and sneezing; itchy, watery eyes; and itchy throat. The product utilizes pseudoephedrine hydrochloride as the active decongestant ingredient.
Barbara Klink. New Product Newswire. Drug Topics 2001;8:74.