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New Product Newswire for October 21, 2002
A new insulin analog formulation in a disposable prefilled doser is now available from Novo Nordisk, Princeton, (800) 727-6500. NovoLog Mix 70/30 (70% insulin aspart [rDNA origin] protamine suspension and 30% insulin aspart [rDNA origin] injection) is indicated for the treatment of patients with diabetes mellitus for hyperglycemia control. It is administered with meals, usually twice a day before breakfast and dinner. The prefilled and disposable NovoLog Mix 70/30 FlexPen, weighing less than an ounce, delivers the insulin discreetly in one-unit increments up to 60 units per injection.
A new indication for the treatment of diabetic nephropathy in patients with hypertension and Type 2 diabetes has been granted to Avapro (irbesartan), from Bristol-Myers Squibb, Princeton, N.J., (609) 252-4000, and Sanofi-Synthelabo. The angiotensin II receptor blocker was earlier approved for treating high blood pressure.
GlaxoSmithKline, Philadelphia, (888) 825-5249, has FDA approval for Augmentin XR Extended Release Tablets (amoxicillin/clavulanate potassium). The beta-lactam antimicrobial is indicated for treating adults with acute bacterial sinusitis or community-acquired pneumonia due to confirmed or suspected beta-lactamase-producing pathogens and S. pneumoniae with reduced susceptibility to penicillin.
Pfizer Inc., New York City, (800) 223-0182, has a new Zithromax TRI-PAK (azithromycin). The TRI-PAK contains three 500-mg tablets, one for each day of a three-day antibiotic treatment for acute bacterial exacerbations of chronic bronchitis.
Sicor Inc., Irvine, Calif., (949) 455-4700, has tentative approval for vinorelbine tartrate injection. The chemotherapeutic drug is indicated for treatment of nonresectable advanced nonsmall-cell lung cancer either as a single agent or in combination with cisplatin. Sicor expects final approval early next year when the period of pediatric exclusivity for GlaxoSmithKline's Navelbine expires ... Another tentative approval for sicor is carboplatin injection. It is indicated for the treatment of patients with ovarian cancer and provides a generic alternative to Bristol-Myers Squibb's Paraplatin.
A generic version of Ortho-McNeil Pharmaceutical's Ortho-Cyclen Tablets oral contraceptive 28-day regimen has been approved for Barr Laboratories, Pomona, N.Y., (800) BARR LABS. The drug, a regimen of 0.250 mg of norgestimate and 0.035 mg of ethinyl estradiol, is used in the prevention of pregnancy. It will be marketed under the name Sprintec.
The FDA has given tentative approval to IVAX Corp., Miami, (800) 980-IVAX, for tamoxifen citrate tablets, 10 and 20 mg. This generic equivalent to AstraZeneca's Nolvadex is used for the treatment of breast cancer.
Hi-Tech Pharmacal Co., Amityville, N.Y., (631) 789-8228, has marketing clearance for timolol maleate ophthalmic solution 0.5%. Timolol maleate is a beta1 and beta2 adrenergic receptor blocking agent used in the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma. It provides a generic alternative to Merck's Timoptic Ophthalmic Solution 0.5%.
Caraco Pharmaceutical Laboratories, Detroit, (313) 871-8400, has FDA clearance for the manufacture and marketing of ticlopidine hydrochloride. The generic approval provides for an alternative to Ticlid, from Roche Laboratories. The product is a platelet aggregation inhibitor for cardiac patients.
Zila Nutraceuticals, Phoenix, (602) 266-6700, has launched a new core product line containing Ester-C Topical Concentrate, a form of natural vitamin C that lasts in emulsions and penetrates the skin layers without chemicals. Sea & Ski Platinum Sunscreen and Skin Care, available in SPF 30 and SPF 50, targets "maturing skin."
A new insulin injection system has marketing clearance from the FDA. The needle-free Injex 30 system is an over-the-counter version of the prescription Injex 30. The device, a product of Equidyne Corp., San Diego, (877) 474-6539) delivers a virtually painless insulin injection through the skin, eliminating needlestick and disposal problems.
For those who love the taste of sugar, and therefore eat too much of this good thing, there is now SweetEnders, a natural lozenge developed by CCA Industries, East Rutherford, N.J., (201) 330-1400. SweetEnders contains an herb (Gymnema sylvestre) that destroys the ability to discriminate "sweet" taste. The product targets sugar instantly, rendering it tasteless for a period of about two hours. It is available in a 90-lozenge bottle.
The Thermoskin Arthritic Glove and Flexible Thumb Splint are two new items from United Pacific, Columbia, S.C., (803) 735-0034. Each is designed to bring pain relief to the hands and fingers of those with arthritis and other painful conditions. A perspiration-wicking fabric layer allows the glove to be worn for extended periods as it provides a therapeutic effect with gentle heat. Gloves are sold in pairs in sizes XS-XXL. The thumb splint helps relieve pain associated with arthritis, tendinitis, and sports injuries by supporting the thumb and restricting joint movement. It is available in left- and right-hand styles.
Just approved for use in children and adolescents age seven to 17 is the GlucoWatch G2 Biographer, a second-generation blood glucose monitoring device that provides glucose readings continuously, automatically, and noninvasively. According to its developer, Cygnus, Redwood City, Calif., (650) 369-4300, it displays glucose levels every 10 minutes, stores up to 8,500 glucose values, and issues user-set personal alert levels if readings are too high or too low or if readings decline rapidly.
Maddak Inc., Pequannock, N.J., (973) 628-7600, has a comfortable SoftCurve grip cutlery that is easier for patients with arthritis or limited hand motion to grasp. The stainless steel knife, fork, teaspoon, and soup spoon are dishwasher safe.
Mead Johnson & Co., Evansville, Ind., (812) 429-5000, a division of Bristol-Myers Squibb, has a new FDA-cleared Enfamil EnfaCare LIPIL infant formula for preterm infants. The formula contains a blend of docosahexaenoic acid (DHA) and arachidonic acid (ARA). The levels of DHA and ARA are consistent with levels recommended by the World Health Organization. Use of DHA and ARA is reported to have a positive effect on the development of a baby's brain and eyes. Mead Johnson launched Enfamil LIPIL for term infants in the United States in February 2002.
Mansfield, Mass.-based Kendall, a business unit of Tyco Healthcare, (509) 261-8023, has added the new SharpStar IV In Room Sharps Container to its family of products. The new four-gallon container has a large lid opening, allowing easier one-handed disposal of large contaminated sharps, including 60-cc syringes with attached needle, blood transfer domes, needle counters, O.R. staplers, and fistula needles. The products are intended for use in a variety of healthcare settings, e.g., hospitals, rehab centers, and long-term care facilities, as well as for home care.
A new, nonpharmacological Peak Performance Sports Inhaler gives off peppermint vapors to help improve an athlete's speed, strength, and endurance and decrease fatigue. The inhaler is the product of Seattle-based HealthCare International, (206) 285-5219.
The Exacta-Med oral dispenser, available in clear and amber, safely and accurately dispenses from 0.5 to 60 mL of medication. For further information, contact Baxa Corp., Englewood, Colo., (800) 567-2292.
A new needle-destruction device makes the disposal of syringes easier for diabetics. From Perfecta Products, Berlin Center, Ohio, (800) 319-2225, comes the DISINTEGRATOR Plus. With the touch of a button, it heats a needle to more than 2500ºC., leaving a blunt nub at the end of the syringe and at the same time eliminating potentially harmful viruses or bacteria. Operating by a rechargeable battery, the unit can disintegrate more than 40 needles between charges.
Nancy Jillard. New Product Newswire. Drug Topics 2002;20:65.