New Product Newswire

NEW PRODUCT NEWSWIRE

Rx

NEW DRUGS

Powderject Pharmaceuticals PLC, Oxford, UK, and its wholly owned subsidiary, Evans Vaccines, London, have received what they claim is the first U.S. approval for a preservative-free flu vaccine. The company will supply Fluvirin, a triple-antigen flu vaccine, in single-dose prefilled syringes. For more information, contact the company at its U.S. branch in Madison, Wis., (608) 231-3150.

NEW DOSING

A smaller unit size of two topical corticosteroid products is now available from Connetics Corp., Palo Alto, Calif., (888) 969-CNCT. Connetics has recently begun offering 50-gram cans of its mid-potency topical corticosteroid Luxiq Foam, 0.12% (betamethasone valerate), and its super-high potency cortico-steroid Olux Foam, 0.05% (clobetasol propionate). The foam formulations, which were available only in 100-gm units, are for the topical treatment of inflammatory and pruritic manifestations of corticosteroid-responsive scalp dermatoses. The smaller unit sizes are designed to offer a more cost-effective option for patients with acute disease or dermatoses with limited involvement. Luxiq was FDA-approved in February 1999; Olux was approved in May 2000.

Novo Nordisk Pharmaceuticals, Princeton, N.J., (800) 727-6500, is offering a new dosing delivery system of its Norditropin (somatropin [rDNA origin] injection) for the treatment of growth hormone deficiency. The company has available its NordiPen 5 delivery system, offering dosing in 0.05-mg increments up to a maximum dose of 1.25 mg. Both NordiPen 5 and the NordiPen 15 delivery system (with dosing from 0.1 mg to 4 mg) are available for use with the NordiPenMate autoinsertion device and are the only delivery systems with premixed cartridges containing Norditropin.

GENERICS

Lannett Co., Philadelphia, (215) 333-9000, has received FDA approval for a reformulated version of its existing ANDA for prednisolone tablets USP, 5 mg. The tablets are indicated for anti-inflammatory treatment necessitated by organ disorders, including endocrine, rheumatic, collagen, dermatologic, ophthalmic, respiratory, gastrointestinal, and neoplastic diseases, as well as meningitis. According to the company, this older product has no current brand-name equivalent.

Bedford Laboratories, Bedford, Ohio, (440) 232-3320, has begun shipping doxycycline for injection USP. The product will be available in vials containing doxycycline hyclate equivalent to 100-mg doxycycline and 480-mg ascorbic acid. The drug is a broad-spectrum tetracycline antibiotic, indicated for infections caused by gram-positive and gram-negative microorganisms. The product offers a generic equivalent for Vibramycin, formerly marketed by Pfizer.

TEVA Pharmaceuticals USA, North Wales, Pa., (888) TEVA USA, is now offering calcitriol capsules, 0.25 mcg and 0.5 mcg. This synthetic vitamin D analog is active in the regulation of the absorption of calcium from the GI tract and its utilization in the body. Calcitriol is indicated in the management of hypocalcemia and the resultant metabolic bone disease in patients who are undergoing chronic renal dialysis. It is also indicated in the management of hypocalcemia and its clinical manifestations in patients with postsurgical hypoparathyroidism, idiopathic hypoparathyroidism, and pseudohypoparathyroidism. The product is AB rated and bio-equivalent to Rocaltrol, from Roche Laboratories.

UDL Laboratories, Rockford, Ill., (800) 848-0462, a subsidiary of Mylan Laboratories, is introducing capsules USP, 50 mg, to its product line. Etoposide capsules is AB-rated and offers a generic equivalent to VePesid, a product of Bristol-Myers Squibb Oncology. The drug is indicated, in combination with other approved chemotherapeutic agents, as first-line treatment in patients with small-cell lung cancer.

NEW DEVICES

Thayer Medical Corp., Tucson, (520) 790-5393, recently introduced LiteAire, a dual-valve holding chamber for dispensing metered-dose inhaler drugs. The device is designed to be more convenient and economical than the costly and bulkier plastic injection-molded devices. International Paper, based in Stamford, Conn., provided its Everest folding carton board for this application, enabling the LiteAire holding chamber to fold flat to fit in a pocket or purse. The LiteAire retail price is between $3.50 and $4, compared with the $18-$40 range of the plastic counterpart.

OTC

Boiron, Newtown Square, Pa., (800) 264-7661, which specializes in homeopathic products, has a new offering plus new packaging for two of its existing products. New Cyclease cramp combines aspirin-, ibuprofen-, and caffeine-free homeopathic medicines in quickly dissolving tablets for relief of menstrual cramps. Chestal cough syrup and Children's Chestal cough syrup now sport new packaging, which displays clear indications and a new "Drug Facts" section about the specific product action of each ingredient.

Colgate Monsters Inc. toothbrushes and toothpaste, inspired by Disney/Pixar's Monsters Inc., a movie scheduled for an early-November release, are now available from Colgate-Palmolive Co., New York, N.Y., (212) 310-2000. The 3-D soft-grip toothbrushes feature four collectible figures from the movie: Mike, Sulley, Boo, and Randall. The brushes are recommended for children ages three to eight, the toothpaste for children ages two to six. The brushes and toothpaste have a suggested retail price of $2.99.

Quigley Corp., Doylestown, Pa., (215) 345-0919, has two new products. Cold-Eeze cinnamon gum contains zinc gluconate glyzine to help shorten the duration of colds. Sugar-free Cold-Eeze tablets, the first OTC cold remedy formulated to help people with diabetes shake their colds faster, have been clinically demonstrated to have no adverse effect on glucose levels.

Bausch & Lomb, Rochester, N.Y., (800) 553-5340, supplied—and is now making available over the counter—a high-potency antioxidant and zinc supplement used by the National Eye Institute in the Age-Related Eye Study. New Ocuvite PreserVision, formulated to aid in the preservation of eye health and vision, contains 500 mg of vitamin C, 400 mg of vitamin E, 15 mg of beta-carotene, 80 mg of zinc as zinc oxide, and 2 mg of copper as cupric oxide.

A toothpaste for whiten teeth and helping to keep them white is available from Rembrandt Oral Care Products, a division of Santa Maria, Calif.-based Den-Mat Corp., (800) 548-3663. Rembrandt Plus Toothpaste with Peroxide, which also comes in gel form, is available in a 2.6-oz. tube at a suggested retail price of $6.99. The product contains no harsh abrasives or cleansers.

A product previously available to consumers only through dentists and other healthcare professionals has now been granted OTC status. Debacterol, a topical treatment to stop the pain of canker sores almost instantly as well as to help heal them, was recently recognized as a pre-amendment drug under the Code of Federal Regulations by the FDA. This recognition allows Debacterol, a previously "grandfathered" product, to be sold over the counter. Debacterol is manufactured by Northern Research Laboratories, St. Paul, (651) 653-3380.

Home Health Care

West Pharmaceutical Services, Lionville, Pa., (800) 345-9800, is releasing its new Clip'n'Ject drug-delivery system, designed to facilitate administration of lyophilized drugs at home. The system, which can be used for reconstitution and delivery of interferons, oncology therapies, vaccines, growth hormones, plasma derivatives, and other freeze-dried or dry-powder drugs, is packaged as a complete set. Clip'n'Ject consists of a plastic connector that links a prefilled diluent syringe with a standard drug vial. The diluent syringe is available in 1-mL, 3-mL, and 5-mL fill sizes.

Ableware, from Maddak Inc., Pequannock, N.J., (973) 628-7600, is introducing two new products for home health care. The Ableware Single AbleRise Bed Rail is designed to assist the user into and out of the bed and to help prevent falls. It also offers a useful storage compartment. For patients with limited upper-extremity movement and decreased grasping ability, the Ableware Maddadapt Built-Up Handle Angled Cutlery provides left- and right-hand forks and spoons with built-up handles angled at 30 degrees for greater maneuverability.

Lifestream Technologies, Post Falls, Idaho, (208) 457-9409, is now making its Lifestream Cholesterol Monitor available at more than 700 pharmacy outlets of Jacksonville, Fla.-based Winn-Dixie stores nationwide. The Lifestream Cholesterol Monitor, with a built-in smart card reader, allows consumers to determine their cholesterol level at home in three minutes. The Data Concern Personal Health Card advanced smart card technology lets the user record up to 200 test results and displays the average cholesterol level across the last six test measurements taken. In addition, this technology allows use of a single device for all members of a family.

 

Barbara Klink. New Product Newswire. Drug Topics 2001;22:55.