New Product Newswire


New Product Newswire for December 8, 2003 issue





A new alpha-blocker has been launched in the United States by Sanofi-Synthelabo, New York City, (212) 551-4000. Uroxatral (alfuzosin hydrochloride extended-release tablets) is available in 10-mg strength for treatment of benign prostatic hyperplasia (BPH). The drug relaxes the muscle surrounding the prostate, bladder neck, and prostatic urethra for relief of BPH symptoms.

Spectracef Tablets (cefditoren pivoxil), approved earlier for Purdue Pharma, Stamford, Conn., (203) 588-8000, are now being shipped. The oral cephalosporin antibiotic should be taken twice a day for 10-14 days. At the 200-mg dosing level, Spectracef is indicated for treating adults and adolescents aged 12 and older for mild to moderate pharyngitis/tonsillitis infections caused by susceptible strains of Streptococcus pyogenes and for uncomplicated skin and skin structure infections caused by susceptible strains of Staphylococcus aureus or S. pyogenes. The 400-mg dosing level is used to treat community-acquired pneumonia and acute bacterial exacerbation of chronic bronchitis caused by susceptible strains of Haemophilus influenzae, H. parainfluenzae, Streptococcus pneumoniae, and Moraxella catarrhalis.


According to CDC, almost three-quarters of botulism cases in the United States have been known to involve infants. BabyBIG (botulism immune globulin) is now FDA-approved for infants younger than one year of age suffering from infant botulism caused by toxin type A or B. Contraindications should be carefully noted to avoid possible severe reactions to this human-derived immunoglobulin. Manufactured by Massachusetts Public Health Biologic Laboratories, Worcester, Mass., and Cangene Corp., Canada, the product is now being distributed by FFF Enterprises, Temecula, Calif., (800) 843-7477.


Schwarz Pharma, Milwaukee, (800) 558-511, has received approval from the FDA to market Kemstro, an orally disintegrating tablet form of baclofen. The tablet disintegrates on the patient's tongue and may be taken without water. The dosing for beginning therapy is the same as for conventional baclofen tablets. Available in 10- and 20-mg strengths, Kemstro is indicated for the alleviation of the spasms associated with multiple sclerosis.


A new five-day dosage form has been approved for Levaquin (levofloxacin) Tablets/Injection and Levaquin (levofloxacin in 5% dextrose) Injection 750-mg once-daily dosing regimens. According to the company, the five-day 750-mg treatment results in 25% less exposure to the drug over the course of treatment, which may help prevent antibiotic resistance. The fluoroquinolone, from Ortho-McNeil Pharmaceutical, Raritan, N.J., (800) 682-6532, is indicated for treating mild to severe community-acquired pneumonia.


There is new labeling for two products from Schwarz Pharma. A geriatric-use subsection now appears in the "Precautions" section of the package insert for Dilatrate-SR (isosorbide dinitrate) Sustained-Release Capsules, to the effect that dose selection for elderly patients should generally start at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function. The drug is used for the prevention of angina pectoris due to coronary artery disease. For Robaxin (methocarbamol tablets, USP), the pediatric-use subsection of the "Precautions" section cautions that safety and effectiveness of Robaxin and Robaxin-750 in pediatric patients below the age of 16 have not been established. Robaxin is used as an adjunct to rest, physical therapy, and other measures for relief of the discomfort associated with painful musculoskeletal conditions.


Schwarz Pharma's Edex (alprostadil for injection) Kit now contains a 10-mL vial of bacteriostatic sodium chloride injection 0.9% and a 3-mL sterile disposable syringe. The prefilled diluent syringe has been removed from the kit. Edex is used for the treatment of erectile dysfunction due to neurogenic, vasculogenic, psychogenic, or mixed etiology.

Kremers Urban Inc., Mequon, Wis., (800) 558-5114, has revised the package insert for omeprazole delayed-release capsules to reflect the use of omeprazole with clarithromycin or with clarithromycin and amoxicillin in the treatment of patients with Helicobacter pylori infection and duodenal ulcer disease. The drug is now being distributed in 10-mg strength.


India-based Dr. Reddy's Laboratories, with U.S. headquarters in Upper Saddle River, N.J., (201) 760-2880, has approval to market an altered version of Pfizer's Norvasc (amlodipine besylate). AmVaz (amlodipine maleate) is not recognized as a traditional generic by the FDA, as a different salt was used in its development. AmVaz will be marketed for the treatment of hypertension.

Barr Laboratories, Woodcliff Lake, N.J., (201) 930-3300, and Ranbaxy Pharmaceuticals have received tentative FDA approval for a generic version of Bristol-Myers Squibb's Glucophage XR. Metformin hydrochloride extended-release tablets, available in 500-mg strength, are indicated as an adjunct to diet and exercise to help improve glycemic control in Type 2 diabetes patients. Glucophage XR is indicated for patients age 17 and older.

TEVA Pharmaceuticals USA, North Wales, PA, (888) TEVA USA, is introducing mupirocin ointment USP, 2%. Available in 22-gm tubes, mupirocin is indicated for the topical treatment of impetigo due to S. aureus and S. pyogenes. The product provides a generic alternative to GlaxoSmithKline's Bactroban Ointment.

Generic fenofibrate capsules, micronized have been approved for Impax Laboratories, Hayward, Calif., (519) 476-2000. The drug is indicated for the treatment of very high serum triglyceride levels and offers an alternative to Abbott Laboratories' Tricor, Micronized.

Watson Pharmaceuticals, Corona, Calif., (909) 270-1400, has final FDA approval for glipizide extended-release tablets. The product, available in 10-mg strength, is indicated as an adjunct to diet and exercise for controlling hyperglycemia in Type 2 diabetes patients if diet alone has proved unsuccessful. This approval provides a generic alternative to Pfizer's Glucotrol XL.


Yerba Maté, derived from the South American holly tree, is lauded as a powerful antioxidant, comparable to vitamin E and green tea. It is said to protect DNA and to inhibit the oxidation of LDL cholesterol. Yerba Maté contains numerous vitamins and minerals and is a significant source of calcium, magnesium, and potassium. It is available from Source Naturals, Scotts Valley, Calif., (800) 815-2333.

Enzymatic Therapy, Green Bay, Wis., (920) 469-1313, has introduced Whole Body Cleanse, a two-week program to detoxify and revitalize the intestines, liver, gall bladder, and circulatory and lymphatic systems and restore the body's natural balance. The herbal cleansing solution contains no dyes or artificial colors.

Loratadine orally disintegrating tablets, 10 mg, from Andrx Corp., Ft. Lauderdale, Fla., (800) 621-7143, are going over the counter. As a bioequivalent version of Schering Plough's Claritin RediTabs, they are indicated for treating the symptoms of seasonal allergic rhinitis. Per an agreement with Andrx, Perrigo Co., Allegan, Mich., (269) 673-9451, will market this bioequivalent version of the product.

Approval also was granted to Perrigo Co. to market two additional OTC medications. Ibuprofen/pseudoephedrine Hydrochloride Oral Suspension, 100 mg/15 mg per 5 mL, is a bioequivalent version of Children's Motrin Cold Oral Suspension, from McNeil Consumer and Specialty Pharmaceuticals. The product is indicated for relief of cold, sinus, and flu symptoms. Loratadine Syrup, 5 mg/5 mL, is bioequivalent to Schering-Plough's Children's Claritin Syrup. The liquid antihistamine is indicated for relief of symptoms of hay fever and other upper respiratory allergies.

Home Health Care

Frazer, Pa.-based Animas Corp. is introducing its third-generation insulin pump—the Animas IR 1200. Said by the company to be the smallest full-feature insulin pump available, it offers low basal insulin delivery, a large screen display, and long battery life. It has been proven waterproof at 12 ft. for 24 hours.

An UltraSling ER shoulder brace is available from dj Orthopedics, San Diego. The soft shoulder brace is designed to position the elbow against the waist area with the forearm externally rotated to a slight degree. This positions the shoulder joint in a way that helps promote healing after surgery or dislocation of the shoulder and prevents recurring injury. For further information, call (800) 336-6569.

An expanded group of ChoiceDM low-sugar or sugar-free meal replacements and snacks, along with foot care, skin care, and oral care products, is being offered by Bristol-Myers Squibb, Princeton, N.J., (609) 252-4000. All products have been developed specifically for diabetes patients.

Health & Beauty Care

Ongoing foot care—for both beauty and health—is available in the form of Flexitol Heel Balm, from Eulactol USA Inc., Boca Raton, Fla., (866) 478-3338. Used as a preventive against dry, painful cracks and blisters, as well as a treatment for more serious foot problems common to diabetes patients, it is available in a 56-gm tube.

SkinCeuticals, Garland, Texas, (800) 811-1660, is giving its skin care products a new package design to reflect the company's scientific and clinical heritage and establish a global SkinCeuticals brand identity. A blue-and-white theme is coupled with a bottle and box design reflecting that of laboratory vessels. SkinCeuticals products fall into six categories: Cleanse/Tone, Prevent, Moisturize, Correct, Protect, and Body.

Nature's Gate Organics, Los Angeles, (323) 650-2201, is enticing customers with a "Buy One, Get One Free" promotion for Nature's Gate Organics Lemongrass & Clary Sage and Chamomile & Lemon Verbena shampoos and conditioners. Chamomile & Lemon Verbena Shampoo recently won Health magazine's "Best/Healthiest Shampoo" award for 2003.


The Baker Co., Sanford, Maine, (800) 992-2537, has a new, smaller BioPROtect walk-in/reach-in safety cabinet. The BioPROtect Jr., built to house high-throughput automated workstations, also accommodates large pieces of laboratory equipment, such as ultra-centrifuges, flow cytometers, aerosol generators, fermentors, and bioreactors. The cabinet provides personnel, product, and environmental protection from bio-aerosols and other particulates.

NasalGuard topical gel will now be available in retail stores. The clear, water-based gel, a drop of which is applied in and around the nostrils, reduces the inhalation of airborne allergens, such as pollen, dust, mold spores, and pet dander, for up to four hours. The product is available in a 7-gm tube from Trutek Corp., Hillsboro, N.J., (908) 359-9136.

Available from Cepia LLC, St. Louis, (314) 725-4900, is a new line of MedSun compliance products. Daily, weekly, and monthly medication organizers, an AM/PM pill pod, a daily or seven-day compact with reminder alarm, a pill cutter/crusher, a 28-day fast-fill system, and numerous tray and wallet organizers are available in a selection of colors and styles.

Four CarbWise high-protein bars with a crunchy soy nugget base, intended for low-carbohydrate diets, are new from CarbWise, Holbrook, N.Y., (866) 234-6483. Each provides more than 20 vitamins, minerals, and nutrients for incorporation into a diet plan as a snack or meal replacement. Flavors to choose from are: Lemon Yogurt, Chocolate Peanut, Chocolate Raspberry, and Chocolate S'Mores.

Available for clinicians, from Baxter Healthcare Corp., Deerfield, Ill., (847) 948-2000, is the Syndeo PCA Syringe Pump, the latest in Baxter's line of patient-controlled analgesia (PCA) devices. The Syndeo pump delivers predetermined doses of pain medication to patients on a prescribed basis. Simple medication programming, with built-in checks and other safety options, allows the clinician more time for patient care.

Sculptors pantyhose can support the legs throughout the day, all the while slimming the hips, flattening the tummy, and shaping the bottom. From SIGVARIS, Peachtree City, Ga., (800) 322-7744, the compression and support stockings come with nude toe and heel for compatibility with any shoe style.

A dual system for treating chronic and traumatic wounds is found in the V.A.C. Instill Wound Therapy System. It cleans, irrigates, and removes infectious materials from patient wounds, administering topical antibiotics, cleansers, antiseptics, and anesthetics. The developer of the product is Kinetic Concepts, San Antonio, (800) 275-4524.

A software enhancement to Medrad Inc.'s Continuum MR Compatible Infusion System enables physicians and nurses to program weight-based dose parameters into the infusion pump, which then calculates and displays the required flow rate for intravenous medication. This eliminates the need for manual calculation of the flow rates. Medrad is based in Indianola, Pa., at (412) 767-2400.


Nancy Jillard. New Product Newswire. Drug Topics Dec. 8, 2003;147:106.

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