Approved in November,
(norelgestromin/ethinyl estradiol transdermal system) is now available to women to prevent pregnancy. Ortho-McNeil Pharmaceutical, Raritan, N.J., claims it is the first birth control patch to be approved by the FDA. When replaced weekly, the patch offers 99% efficacy when used appropriately. For more information, call (877) BC-PATCH.
Paxil CR (paroxetine HCl) Controlled Release, a product of GlaxoSmith-Kline, Philadelphia, (888) 825-5249, offers a new formulation of GSK's serotonin reuptake inhibitor Paxil. Paxil CR combines the efficacy of paroxetine with an advanced technology that controls dissolution and absorption of the drug in the body. The orally administered anxiolytic/antidepressant drug is FDA-approved for the treatment of major depressive disorder and panic disorder, with improved patient tolerability and lower patient dropout, according to the company.
Revised labeling has been approved for Metadate CD (methylphenidate HCl) Extended-Release Capsules 20 mg, from Celltech Pharmaceuticals, Rochester, N.Y., (716) 475-9000. The recommended dose of the ADHD drug can now be sprinkled onto a small amount of soft food, such as applesauce. The company says it's the first once-daily methylphenidate product to receive this approval, making it easier for ADHD patients who experience difficulty in swallowing to adhere to their medication regimen.
The FDA has cleared the Nutropin AQ Pen for exclusive use with the Nutropin AQ Pen Cartridge, for delivering Nutropin AQ (soma-tropin [rDNA origin] injection), a human growth hormone. The pen, designed and manufactured for Genentech, South San Francisco, (650) 225-1000, gives patients a simple, convenient way to administer their growth hormone replacement therapy from a single prefilled 10 mg/2 ml cartridge.
Fougera, Melville, N.Y., (800) 645-9833, a division of Altana Inc., has FDA approval to market generic desonide lotion 0.05%, a topical corticosteroid. The product provides an alternative to Galderma's DesOwen, which is indicated for the relief of inflammatory and pruritic manifestation of corticosteroid-responsive dermatoses. It will be available in 59-ml and 118-ml bottles. Desonide ointment 0.05%, approved earlier, will be available in 15- and 60-gm tubes.
The FDA has given ANDA approval to KV Pharmaceutical Co., St. Louis, (800) 447-4537, for prednisolone syrup 15 mg/5 ml and 5 mg/5 ml. As a generic equivalent to Prelone, from Muro Pharmaceutical, the glucocorticoid is indicated for the management of a variety of disorders, including endocrine, rheumatic, dermatologic, allergic, ophthalmic, respiratory, hematologic, and other diseases.
Roxane Laboratories, Columbus, Ohio, (614) 272-4774, is introducing two new generic products. Megestrol acetate oral suspension, 40 mg/ml, is indicated for the treatment of anorexia, cachexia, or unexplained significant weight loss in patients diagnosed with AIDS. The medication, claimed to be bioequivalent to Bristol-Myers Squibb's Megace, is packaged in 240-ml bottles and comes with a calibrated dosage cup. Midazolam hydrochloride syrup 2 mg/ml offers a generic alternative to Roche Laboratories' Versed syrup. The benzodiazepine is used in pediatric patients for sedation, anxiolysis, and amnesia prior to diagnostic, therapeutic, or endoscopic procedures or before the induction of anesthesia.
Approval has been granted to Andrx Corp., Fort Lauderdale, Fla., (800) 621-7143, for two strengths (10 and 20 mEq) of potassi- um chloride extended- release tablets, a generic alternative to Schering-Plough's K-Dur. The potassium supplement is used to treat low blood potassium levels, a common occurrence in people taking certain drugs to treat high blood pressure.
American Pharmaceutical Partners, Los Angeles, (800) 551-7176, has entered into an agreement with SuperGen Inc. for the sale and distribution of mitomycin. Available in 5-mg and 20-mg strengths, the product offers a generic equivalent to Mutamycin, from Bristol-Myers Squibb, used in treating adenocarcinoma of the stomach and pancreas along with other approved chemotherapeutic agents.
Boehringer Ingelheim, Ridgefield, Conn., (203) 798-4700, is reintroducing Dulcolax to its portfolio following a 10-year licensing agreement giving Novartis marketing rights to the laxative. The relaunch will be supported by a $10 million advertising and promotion campaign. The stimulant laxative, featuring updated packaging graphics, is available both in tablets (in 10-, 25-, 50,- and 100-count packages) and in suppositories (in 4-, 8-, 16-, 28-, and 50-count packages).
Toward the pursuit of greater muscle endurance, resistance, and strength, Rehabilicare Inc., New Brighton, Minn., (651) 631-0590, has been cleared by the FDA for over-the-counter sale of its Compex Sport muscle stimulator in the United States. According to the company, electrostimulation can help athletes and other individuals develop effective personalized training programs to supplement conventional workouts for enhanced performance.
The FDA has granted 510(k) clearance for LAM IPM Wound Gel for over-the-counter use in the treatment of minor cuts and abrasions. The clear, odorless gel, composed principally of sodium hyaluronate, a derivative salt of hyaluronic acid, keeps the wound moist, aiding in the healing process. The gel is a product of LAM Pharmaceutical Corp., Lewiston, N.Y., (877) 526-7717.
From Martin Health Group, Sudbury, Ontario, (888) 867-9673, come two new products. Pine of Life, an antioxidant and anti-inflammatory, has among its principal ingredients pine bark extract and natural vitamin C. The product was formulated to provide energy and rebuild the immune system. Nature-Slim, a dietary supplement, helps to curb the appetite for those wishing to lose weight.
Promoted as "pills you can drink" are once-daily liquid nutritional supplements from Remington Health Products, Fort Worth, (817) 847-0605. Drinkables Calcium 3 supplies three sources of calcium plus vitamin D, magnesium, vitamin K, zinc, and sodium borate for helping cartilage and bones. Drinkables Colloidal Minerals offers 74 minerals and trace elements derived from land and sea sources. Drinkables Joint Care provides glucosamine HCl, chondroitin sulfate, MSM, and collagen to fight against the breakdown in cartilage. Each bottle contains 16 1-oz. doses.
Novo Nordisk Pharmaceuticals, Princeton, N.J., (800) 727-6500, has an upbeat, colorful look in its new NovoPen Junior insulin delivery system for children and teenagers. Designed to deliver half-unit increments, the device is used with the company's PenFill 3-ml cartridges and NovoFine disposable needles.
From SpectRx Inc., Norcross, Ga., (770) 242-8723, comes the SimpleChoice Easy disposable insulin pump infusion set. The soft catheter infusion set is compatible with major insulin pump brands and comes in two tubing lengths. Infusion sets, attached to external pumps, provide a steady stream of insulin and are changed approximately every three days. Also approved for SpectRx is an improved insulin patch infusion set for use with all major brands of insulin pumps. The new device delivers insulin through five tiny, flexible cannulas said to be much smaller than ordinary insulin pump infusion needles, thus reducing the discomfort associated with insulin pump infusion.
Health & Beauty Care
Del Laboratories, Uniondale, N.Y., (800) 952-5080, is offering several N.Y.C. NEW YORK COLOR products. For women on the go, there's the On Location Complete Makeup Kits compact for touching up eye shadow and lip color. Blush Eyeshadow Trios, available in five color palettes, help create special eye effects. A long-lasting lip-color system, Lipforever, offers a color applicator at one end, a polishing applicator at the other. Color Brush On Lip Glaze, with vitamin E, is available in 10 shades to color, moisturize, and shine lips.
Two companies are introducing preterm infant formula containing the fatty acids DHA (docosahexaenoic acid) and ARA (arachidonic acid). From Abbott Laboratories' Ross Products division, Columbus, Ohio, (800) 986-8510, comes NeoSure preterm infant formula, and from Mead Johnson Nutritionals, Evansville, Ind., (312) 988-2293, Enfamil Premature. The fatty acids are believed to provide nutrition that more closely emulates breast milk and significantly improves both the mental and visual development of formula-fed babies.
Huot Manufacturing, St. Paul., (800) 832-3838, has a new Securitab transparent plastic package for protecting, displaying, and merchandising products. A self-hanging tab allows multiple products to be hung from display racks; the package can also be used for single-unit products such as CDs, videos, electrical components, hardware, and sporting goods.
The Thomson Corp., Greenwood Village, Colo., and Montvale, N.J., is making available three bioterrorism response information products through its MICROMEDEX and Medical Economics businesses: The MICROMEDEX BioDex System provides access to electronic information on identification, protection, and treatment of bioterrorism agents for PCs and handheld devices for on-the-scene response; the PDR Guide to Biological and Chemical Warfare Response details symptoms of more than 50 biolog-ical and chemical agents, with recommended treatments; Bioterrorism and Public Health: An Internet Resource Guide presents an extensive listing and descriptions of a broad range of Web-based resources on biological and chemical terrorism. For further information, call (800) 525-9083.
New from BIC Consumer Products, Milford, Conn., (203) 783-2000, are several colorful pens and a new correction film. The BIC XXL offers a retractable roller ball pen with a foam grip in a variety of neon colors. The BIC Z4 Free-Ink Roller ball pen, with rubber grip, is available with a fine or microfine point in a range of colors, including black. The BIC Gel Intensity pen, in black, metallic, or pastel ink, comes with a transparent barrel and in three point sizes. Available with black ink with three barrel colors is the BIC Intensity Clic Gel pen, with retractable roller, which offers black ink, a fine point, and comes in three barrel colors. Wite-Out Exact Liner Correction Film offers ease of correction with the comfort of a pen.
Cushioned, anti-fatigue rubber mats offer pharmacists support for the back and legs, along with relief from tired feet. The cushioned mats, with rubber surface bonded to a sponge rubber base, are available in a variety of sizes and colors from Easy Designs, St. Charles, Mo., (800) 729-3279.
New, thinner Huggies Pull-Ups training pants, from Kimberly-Clark, Dallas, (972) 361-4011, now offer an improved fit under children's clothingas well as the feeling of real underwear. The disposable training pants also have bolder, more colorful graphics with a new and enhanced gender-specific look.
Boston-based ZonePerfect Nutrition Co., (617) 423-1080, claims to have a satisfying solution to a "time-starved world." The company is offering three new flavors of its healthy nutrition barsfudge graham, chocolate peanut butter, and blueberry yogurt. The bars, which provide a precise ratio of carbohydrates, protein, and fat, include Omega-3 fatty acid and 19 essential vitamins and minerals.
Surface Safe is a unique two-step system for cleaning and inactivating chemotherapy agents on inert work surfaces and eliminating potential surface damage on those surfaces. Each applicator kit contains two packets of premoistened towelettesone with sodium hypochlorite to inactivate most anticancer drugs, and one that neutralizes the hypochlorite to eliminate surface damage. The maker is SuperGen Inc., Dublin, Calif., (925) 560-0101.
Nancy Jillard. New Product Newswire. Drug Topics 2002;10:95.