New Product Newswire
The FDA has granted Astra Zeneca, Wilmington, Del., (800) 236-9933, approval of 5-mg of Zomig-ZMT (zolmitriptan) Orally Disintegrating Tablets. The drug is indicated for the acute treatment of migraine with or without aura in adults. The orange-flavored tablet dissolves on the tongue without additional liquids. The drug is also available in a 2.5-mg strength.
A new formulation of Reminyl is now available from Janssen Pharmaceutica, Titusville, N.J., (800) JANSSEN. Janssen has received approval for Reminyl Oral Solution (galantamine hydrobromide), 4 mg/mL, for the treatment of mild to moderate dementia of the Alzheimer's type. The clear, colorless solution is supplied in 100-mL bottles, with a pipette calibrated in milligrams and milliliters. Reminyl is also available in 4-mg, 8-mg, and 12-mg tablets.
Odyssey Pharmaceuticals, East Hanover, N.J., (877) 427-9068, a wholly owned subsidiary of Sidmak Laboratories, is introducing Surmontil (trimipramine maleate) in 25-, 50-, and 100-mg capsules. The tricyclic antidepressant works by raising the brain's level of norepinephrine. It also acts as a sedative. The registered trademark and NDA for Surmontil were purchased by Odyssey from American Home Products Corp.
Summers Laboratories, Collegeville, Pa., (800) 533-SKIN (7546), has purchased Vanoxide-HC (benzoyl peroxide 5% and hydrocortisone 0.5%) from Dermik Laboratories. Vanoxide-HC is a topical, water-based lotion used in the treatment of acne and is claimed to be the only benzoyl peroxide lotion with anti-inflammatory activity.
NovoLog (insulin aspart, rDNA origin) injection, a new rapid-acting insulin analog, is now available nationally for the treatment of diabetes. Because it has a more rapid onset and shorter duration of action than regular human insulin, NovoLog injection should normally be used in regimens together with intermediate or long-acting insulin and should be followed immediately by a meal. The drug, a product of Novo Nordisk Pharmaceuticals, Princeton, N.J., (800) 727-6500, has been approved by the FDA since June 2000.
Upsher-Smith Laboratories, Plymouth, Minn., (800) 654-2299, recently launched AB-rated generic versions of sustained-release potassium chloride in both 20-mEq and 10-mEq strengths. Klor-Con M20 (potassium chloride extended-release tablets, USP) and Klor-Con M10 (potassium chloride extended-release tablets, USP) are bioequivalent to Key Pharmaceuticals' K-Dur 20 mEq and 10 mEq, respectively. Klor-Con M20 and M10 are indicated for the treatment of patients with hypokalemia, with or without metabolic alkalosis, in digitalis intoxication, and in patients with hypokalemic familial periodic paralysis. The drug is also indicated for the prevention of hypokalemia in patients who would be at particular risk if hypokalemia were to develop. According to the company, the drug should be administered only to patients who can't or won't take liquid or effervescent potassium preparations.
Barr Laboratories, Pomona, N.Y., (800) BARRLAB; IVAX Corp., Miami, (800) 327-4114 (ext. 5172); and Eon Labs Manufacturing, Laurelton, N.Y., (800) 526-0225, have each been granted FDA approval for flutamide capsules, USP, 125 mg, the generic equivalent of Schering Corp.'s Eulexin capsules. The drug is indicated for use in combination with luteinizing hormone-releasing hormone (LHRH) agonists for the management of locally confined stage B2-C and D2 metastatic carcinoma of the prostate.
Eon Labs Manufacturing has also obtained the FDA's OK for enalapril maleate-hydrochlorothiazide tablets, a generic version of Merck & Co.'s branded antihypertensive Vaseretic. This combination ACE inhibitor/ diuretic will be available in the same strengths as the branded version: 10 mg/25 mg and 5 mg/12.5 mg.
Mylan Laboratories, Pittsburgh, (412) 232-0100, also offers enalapril maleate-hydrochlorothiazide tablets in strengths of 10 mg/25 mg and 5 mg/12.5 mg following the FDA's approval of this generic version of Merck's Vaseretic. The drug, indicated for the treatment of hypertension, can be used alone or in combination with other antihypertensive agents.
St. Jude Medical, St. Paul, (651) 483-2000, and LifeScan, Milpitas, Calif., (800) 227-8862 (exts. 4023, 4344), a Johnson & Johnson company, have recently reached an exclusive U.S. marketing agreement to promote the Harmony INR Monitoring System. Developed by LifeScan, this anticoagulation blood monitoring system consists of a handheld electronic monitor and disposable, single-use test strips. The product, recently cleared for marketing, should be available next year to healthcare professionals and by prescription to patients who have completed a training program on the device's use.
A new trade name for the female condom previously called Reality is now being established by the company owning the rights to the product, The Female Health Company, Chicago, (800) 635-0844. The pro-duct's new name is FC Female Condom. For use by women, it is made of polyurethane and can be used to help protect against unwanted pregnancy and sexually transmitted diseases. The condom is manufactured in London.
Spear Pharmaceuticals, Titusville, Fla., (866) SPEAR-RX (773-2779), following the termination of a distribution agreement with Geneva Pharmaceuticals, will begin marketing four tretinoin generics under its own brand name. Spear Dermatology Products, a wholly owned subsidiary of Spear Pharmaceuticals, will market three strengths of tretinoin cream0.025%, 0.05%, and 0.1%and a 0.025% strength of tretinoin gel. The generics will be manufactured by DPT Laboratories, a San Antonio-based firm. Spear received ANDA approvals in December 1998 for the cream and in February 2000 for the gel. Both product families have previously been distributed by Geneva Pharmaceuticals. The products offer generic alternatives to Ortho Dermatological's Retin-A Cream and Gel.
A new toothpaste for children is now available from Del Pharmaceuticals, Uniondale, N.Y., (516) 844-2300. New Orajel Toddler Training Toothpaste is specially form-ulated for children 18 months to four years. The toothpaste contains a patented ingredient, Microdent, to help clean teeth as well as to remove and prevent plaque. According to the company, the toothpaste is fluoride-free, nonfoaming, nonabrasive, and safe to swallow. Each flavorBubble Burst and Fruit Splashis packaged with the graphic of Maurice Sendak's Little Bear.
Naturally Vitamins, Phoenix, (800) 899-4499, is introducing a new product in its Inuflora nutraceutical line. Inucal is a sugar-free, chocolate, chewable calcium supplement that provides 500 mg of calcium. According to the company, the product also contains 300 mg of the branded ingredient Inuflora, a prebiotic, nondigestible fiber that helps promote beneficial bacteria in the colon.
E-Z-EM Inc., Westbury, N.Y., (800-544-4624), has brought out the first meal kit designed to replace a clear liquid diet before examination of the colon. NutraPrep contains a complete day's worth of shakes, soup, energy bars, and chips, which are specially prepared to provide essential nutrition, while significantly reducing the amount of residue remaining in the bowel after digestion. The NutraPrep kit comes with simple instructions, and each food and beverage item is labeled to indicate the time of day it is to be used. NutraPrep can also be used with a laxative preparation.
Now available from Novo Nordisk, Princeton, N.J., (800) 727-6500), and Life-Scan, Milpitas, Calif., (408) 263-9789, is the InDuo System. According to the manufacturer, it is the first device ever to combine blood glucose monitoring and insulin delivery into one compact device. The system requires only a tiny drop of blood (one microliter), allowing users to take a blood sample from the arm rather than the finger. The device provides clinically accurate test results in five seconds. In addition, it remembers the amount of insulin injected at the last dose, along with the time elapsed since that dosing. The resulting information offers diabetic patients the ability to make more informed dosing decisions.
Ableware is introducing a new plate specially designed for more convenient eating among children and the elderly, as well as individuals with limited muscle control and those with the use of only one hand. The Ableware Inner Lip Plate with Suction Cup Base has a deep inner lip that helps keep food from sliding off the plate, as the plate itself is held in place. The user is able to bring a fork or spoon to the edge of the plate, then push the food onto the utensil by sliding it up against the lip. The plate, available from Maddak Inc., Pequannock, N.J., (973) 628-7600, is nine inches in diameter and is made of durable plastic.
Barbara Klink. New Product Newswire. Drug Topics 2001;21:47.