NEW PRODUCT NEWSWIRE

Rx

NEW INDICATIONS

Pravachol (pravastatin sodium) has received approval for a new pediatric indication. A product of Bristol-Myers Squibb, Princeton, N.J., (609) 252-4000, the drug can now be used for young patients eight years and older with heterozygous familial hypercholesterolemia.

Bristol-Myers Squibb's Tequin (gatifloxacin) is now approved for uncomplicated skin and skin structure infections, including abscesses, furuncles, folliculitis, wound infections, and cellulitis due to methicillin-susceptible Staphylococcus aureus and to Streptococcus pyogenes. The approval covers both tablets and injection.

New indications for two medications have been approved for Pfizer Inc., New York City, (800) 438-1985. The cholesterol-lowering medication Lipitor has been approved for treatment of familial hypercholesterolemia in children 10 to 17 years of age. And Zyrtec (cetirizine HCl), an antihistamine, can now be used in infants six months of age and older for seasonal allergic rhinitis, perennial allergic rhinitis, and chronic idiopathic urticaria.

Aciphex, a proton pump inhibitor, has gained FDA approval for use in Helicobacter pylori eradication to reduce the risk of duodenal ulcer recurrence. Aciphex, a product of Eisai Inc., Teaneck, N.J., (201) 287-2000, is approved for administration for seven days and is used along with antibiotics.

NEW FORMULATIONS

Biovail Corp., Toronto, (416) 285-6000, has received tentative FDA approval for an orally disintegrating formulation of the nonbenzodiazepine hypnotic compound zolpidem. Sold under the brand name of Ambien (Sanofi-Synthelabo), zolpidem is indicated for the short-term treatment of insomnia.

NEW PACKAGING

The FDA has approved a 60-dose configuration of the nitroglycerin spray Nitrolingual Pumpspray (0.4 mg nitroglycerin per spray) for First Horizon Pharmaceutical Corp., Alpharetta, Ga., (770) 442-9707. This new size is smaller and more convenient to carry than the currently available 200-dose bottle. The medication is indicated for acute relief or prevention of chest pain associated with angina pectoris.

NEW GENERICS

Andrx Corp., Fort Lauderdale, Fla., (800) 621-7143, has tentative approval for loratadine rapidly disintegrating tablets, an antihistamine indicated for relief of seasonal allergic rhinitis. This form of loratadine, bioequivalent to Schering-Plough's Claritin Reditabs, disintegrates on the tongue within seconds, with or without water.

For Caraco Pharmaceutical Laboratories, Detroit, (313) 871-8400, comes FDA approval for clozapine, indicated for the treatment of schizophrenia. This approval provides a generic alternative to Clozaril, from Novartis.

SuperGen Inc., Dublin, Calif., (925) 560-0101, is cleared to market Mitozytrex (MitoExtra), a proprietary version of generic mitomycin. The drug is used in the therapy of disseminated adenocarcinoma of the stomach or pancreas in proven combinations with other approved chemotherapeutic agents and as a palliative treatment when other therapies have failed.

East Hanover, N.J.-based Sidmak Laboratories, (800) 922-0547, through a joint venture with Banner Pharmacaps, is introducing ethosuximide, USP, 250-mg soft-gel capsules for the control of absence (petit mal) epilepsy. Approval of the anticonvulsant provides a generic alternative to Zarontin, from Parke-Davis.

Amoxicillin and clavulanate potassium tablets, USP, have been approved in 500 mg/125 mg and 875 mg/125 mg strengths for TEVA USA, North Wales, Pa., (888) TEVA USA. The product, a generic alternative to SmithKlineBeecham's Augmentin tablets, is indicated in the treatment of such conditions as sinusitis, otitis media, lower respiratory tract infections, urinary tract infections, and skin and skin structure infections caused by susceptible strains of a variety of organisms.

Barr Laboratories, Pomona, N.Y., (800) BARR LAB, has approval for flecainide acetate tablets, a generic version of 3M's Tambocor. Available in 50-, 100-, and 150-mg strengths, the antiarrhythmic medication is indicated for suppression of ventricular arrhythmias.

Amiodarone hydrochloride injection, from Bedford Laboratories, Bedford, Ohio, (440) 232-3320, has gained FDA approval. A generic version of Wyeth's Cordarone I.V., the drug is indicated for initiation of treatment and prophylaxis of frequently recurring ventricular fibrillation and hemodynamically unstable ventricular tachycardia in patients refractory to other therapy.

Impax Laboratories, Hayward, Calif., (510) 476-2000, has been granted final FDA approval of 10- and 20-mg strengths of omeprazole delayed-release capsules and tentative approval for 40-mg capsules of the same medication. Indicated for treatment of duodenal/gastric ulcers and gastroesophageal reflux disease, the product is a generic version of AstraZeneca's Prilosec.

Two companies will be marketing isotretinoin soft gelatin capsules in 10-mg, 20-mg, and 40-mg strengths: Genpharm Inc., Toronto, (416) 236-2631, and Mylan Laboratories, Pittsburgh, (412) 232-0100. The product, which will provide a generic alternative to Roche's Accutane capsules, is indicated for the treatment of severe recalcitrant nodular acne.

Fougera, Melville, N.Y., (800) 225-5500, has reintroduced neomycin and polymyxin B sulfates and dexamethasone ophthalmic ointment, USP. This topical antibiotic and steroid combination ointment offers a generic alternative to Falcon Pharmaceuticals' Maxitrol Ophthalmic Ointment. It is indicated for the treatment of eye infections and to relieve the redness, irritation, and discomfort associated with various eye problems and is available in 1/8-oz. tubes.

OTC

Centrum Kids has a new licensing agreement with Nickelodeon for the launch of Centrum Kids Jimmy Neutron Multivitamins. According to Wyeth Consumer Healthcare, Madison, N.J., manufacturer of the product, the chewable vitamin/mineral supplement provides children with more vitamins and minerals than comparable leading brands. They come in three flavors: cherry, orange, and fruit punch. For more information, call (973) 660-6923.

Leiner Health Products, Carson, Calif., (310) 952-1534, is offering a private-label brand alternative to Wyeth's Advil Liqui-gels. The company is making available Leiner's liquid ibuprofen softgel capsules in 200-mg strength.

Pilot Therapeutic Holdings, Winston-Salem, N.C., (336) 725-2222, has developed a leukotriene-blocking product called Airozin. This natural dietary formulation helps regulate key metabolic pathways, such as leukotriene biosynthesis, in an effort to lower the inflammatory component of asthma.

Home Health Care

An extended reach is available through the 24-in.-long Raptor lightweight reacher from Maddak Inc., Pequannock, N.J., (973) 628-7600. The jaw, which opens to two and a half inches, enables a tight grip on slim or bulky items. The device weighs six ounces and extends the reach by two feet.

Pheromone Sciences Corp., Toronto, (800) 937-3095, has been given FDA approval for its PSC Fertility Monitor. The watch-like monitoring device predicts ovulation up to four days prior to the day of ovulation by measuring changes in perspiration ions on the skin's surface.

From HemoSense Inc., Milpitas, Calif., (408) 934-4125, comes the INRatio Self-Test PT Monitoring System for patients on oral anticoagulant therapy. The device has been cleared by the FDA for home use as well as use in a phy-sician's office or clinical setting. INRatio is a portable, handheld analyzer that measures and records blood clotting time via prothrombin-time (PT) testing to help ensure safe and effective anticoagulant use.

Health & Beauty Care

A new disposable triple-blade razor will soon be available from Gillette Co., Boston, (617) 421-7000. The Sensor 3 is being billed as the "best-performing" razor on the market, and it will also sport a higher price than its closest rivals. The razor combines a refillable cartridge razor with a third blade, as found in Gillette's Mach3 and Venus shavers.

Den-Mat Corp.'s Rembrandt Oral Care division, Santa Maria, Calif., (800) 548-3663, promises a stain-free smile with the Rembrandt Intense Stain Removal Bleaching Kit. In two weeks, treating twice daily for 15 minutes with a mouthguard containing an extra-strength cleaning ingredient and a patented bleaching formula, smokers and coffee/tea/red wine drinkers can purportedly have whiter teeth by seven shades. Also included in the kit is Rembrandt Intense Stain Removal Toothpaste to help maintain the whiter teeth.

Also from Rembrandt Oral Care comes the single-application Rembrandt Quick White disposable bleaching kit for teeth. This mouthguard bleaching system contains 28 unit-dose disposable capsules with mint-flavored bleaching gel along with 28 disposable mouth guards. According to the company, the product will dramatically whiten teeth with a single 20-minute application every day for two weeks.

Etc.

With the look and feel of a real camera, the one-time-use Fujicolor QuickSnap Flash boasts a large viewfinder and legible exposure counter. The flash range extends to 14 feet, and the continuous flash recharges in five seconds. It is from Fuji Photo Film U.S.A., Elmsford, N.Y., (914) 789-8145.

Medline Industries, Mundelein, Ill., (800) 633-5463, has introduced E*Kits with ChloraPrep One-Step as an aid in reducing the likelihood of catheter-related bloodstream infections in such procedures as debridement, incision and drainage, wound care, circumcision, biopsy, and skin staple removal. ChloraPrep is a broad-spectrum antiseptic that helps reduce the number of microorganisms on the skin, thus working to lessen the possibility of nosocomial infection.

Sporting an award for excellence from American Tasting Institute is the Xenadrine high-protein weight-control bar from Cytodyne Technologies, (732) 363-3032. The Manasquan, N.J.-based company is the maker of the low- carbohydrate bar. Each bar contains 21 gm of protein, fortified with glutamine, key amino acids, 26 essential vitamins and minerals, and 1.5 gm of Clarinol, a rich source of conjugated linoleic acid that promotes weight loss by decreasing body fat and increasing lean body mass and muscle strength.

As a first line of defense against radiation contamination, Syncor Radiation Management, Cleveland, (440) 248-9300, has a new Emergency Responder Kit especially for hospitals. Each kit has: a Promask full-face respirator with nuclear, biological, and chemical filters; microprocessor-based survey meters and probes; a Primalert 35 area monitor; a CAL/RAD multi-channel analyzer for isotope identifications; dosimeters for measuring radiation; cleaners, decontaminants, and containers for contaminated clothing; protective clothing, and accessories.

To meet the storage requirements of anesthesia personnel, there are new anesthesia carts from Lionville Systems, Exton, Pa., (610) 363-9100. The carts come with a variety of options, including narcotics drawers with keyless entry and automatic relocking, a cart auditing system, large storage drawers with various organizing configurations, spacious work areas, and over-the-counter storage options.

Available from Medical Technology Systems, Clearwater, Fla., (727) 576-6311, are proprietary packaging systems for use by pharmacies dispensing Rx medications to nursing homes, assisted-living, and correctional facilities. It has now expanded its Plus Pack medication compliance punch cards to include 31-day and seven-day punch cards for both heat-seal and pressure-sensitive (cold-seal) applications. Punch cards assist with complex drug regimens by organizing medications by time of day.

 

Nancy Jillard. New Product Newswire. Drug Topics 2002;23:102.