New Product Newswire

NEW PRODUCT NEWSWIRE

Rx

NEW INDICATION

An additional treatment option is now available for patients with diabetes. NovoLog (insulin aspart [rDNA origin] injection), the rapid-acting insulin analog from Novo Nordisk Pharmaceuticals, Princeton, N.J., can now be used in an external pump system. According to the company, this is the first and only FDA approval for this indication for an insulin analog; the product was already available in cartridges and vials for controlling hyperglycemia in diabetes mellitus in adult patients. The new indication allows for continuous insulin administration. An external insulin pump, about the size of a pager and worn on the body, can be set to deliver a predefined amount of insulin automatically into the subcutaneous tissue of the abdomen throughout the day. For further information, call (609) 919-7776.

NEW DELIVERY FORM

Novartis Pharmaceuticals, East Hanover, N.J., (973) 781-8300, is switching its Diovan (valsartan) 80-mg and 160-mg formulations from capsule to tablet form. Diovan, an angiotensin II receptor blocker, is being converted from capsule to tablet form in order to standardize the Diovan and Diovan HCT (valsartan/hydrochloro-thiazide) product line. Diovan is offered in 80-, 160-, and 320-mg strengths for control of hypertension; Diovan HCT is available in 80/12.5- and 160/12.5-mg strengths for patients who are in need of additional blood pressure control beyond that provided with either valsartan or hydrochlorothiazide alone.

NEW DISTRIBUTION

Questcor Pharmaceuticals, Union City, Calif., (510) 400-0700, has signed an agreement with VSL Pharmaceuticals to promote, sell, and distribute VSL#3 in the United States. The product is a patented probiotic preparation of eight live, freeze-dried lactic acid bacterial species. Questcor claims that VSL#3 contains a significantly greater concentration of live bacteria and more bacterial species than traditional probiotic preparations. The agreement allows the company to extend its presence in the gastrointestinal market with a product that targets overall health as well as digestive system balance.

NEW GENERICS

Several companies—Purepac Pharmaceutical Co., Elizabeth, N.J., (908) 527-9100, the newly acquired subsidiary of Alpharma Inc.; Eon Labs Manufacturing, Laurelton, N.Y., (718) 276-8600; Mylan Laboratories, Pittsburgh, (412) 232-0100; and TEVA USA, North Wales, Pa., (888) TEVA USA)—have been granted FDA approval for their Abbreviated New Drug Applications for 10-mg, 20-mg, and 40-mg lovastatin tablets USP. The product, an HMG-CoA reductase inhibitor, offers a generic alternative to Mevacor, from Merck & Co. Mevacor is indicated for the treatment of high cholesterol, in combination therapy in primary prevention of coronary heart disease, and to slow the progression of coronary heart disease.

Purepac Pharmaceutical Co., Elizabeth, N.J., (908) 527-9100, has also received FDA approval to manufacture and market ethylphenidate hydrochloride extended-release tablets, 20 mg. The product, the generic equivalent of Ritalin-SR from Novartis, is indicated in the treatment of attention deficit hyperactivity disorder and narcolepsy.

IVAX Corp., Miami, (305) 591-3777, has been granted tentative FDA approval for its ADNA for lisinopril tablets in 2.5-, 5-, 10-, 20-, 30-, and 40-mg strengths. Lisinopril, used to treat hypertension, heart failure, and acute myocardial infarction, provides a generic alter-native to AstraZeneca's ACE inhibitor Zestril. IVAX expects to launch and market the new drug immediately following the June 2002 expiration of the pediatric exclusivity period for the branded version.

Par Pharmaceutical, Spring Valley, N.Y., (845) 425-7100, a unit of Pharmaceutical Resources Inc., has received tentative approval for 200-, 300-, and 400-mg dosages of ofloxacin injection. This generic form of Floxin, a fluoroquinolone antibiotic from Johnson & Johnson, is indicated to treat mild to moderate infections.

From United Research Laboratories/Mutual Pharmaceutical Co., Philadelphia, (800) 523-3684, comes word that Mutual Pharmaceutical has received FDA approval of its ANDA for sotalol hydrochloride tablets USP in 80-mg, 120-mg, 160-mg, and 240-mg strengths. Approval for this product provides a generic alternative to Betapace, an anti-arrhythmic drug from Berlex Laboratories. The drug is indicated for the treatment of documented ventricular arrhythmias that in the opinion of the physician are life-threatening.

NEW DEVICES

For the nearly 15 million asthma sufferers in the United States, there is now available "the world's smallest, lightest nebulizer compressor," according to its manufacturer, Omron, Vernon Hills, Ill. The CompAir Elite is an 8-oz. handheld device, 5 in. high, small enough to be carried in a purse or briefcase. The company claims that the nebulizer operates so efficiently that treatment times using most medications are cut by more than one-third. An optional battery pack is available for use in hiking, camping, and travel. For further information, contact the company at (847) 680-6200.

OTC

From Paddock Laboratories, Minneapolis, (800) 328-5113, come EZ-Char Pellets activated charcoal USP. Packaged in a 25-gm bottle and available through wholesalers, the pellets must be reconstituted in water for administration to conscious victims of poisoning emergencies.

Shipping now to subsidiaries of Albertson's Inc. are two products from NatureWell Inc., La Jolla, Calif., (858) 454-6790: MigraSpray, a sublingual spray, and MigraDaily, a tablet. Both products contain the herb feverfew and are intended to provide rapid relief from migraine and other types of headaches.

AmLactin AP Anti-Itch moisturizing cream, from Upsher-Smith Laboratories, Minneapolis, (763) 473-4412, is a fragrance-free, nonsteroidal cream that relieves itchy skin temporarily as it moisturizes and softens. The product contains 1% pramoxine HCl and 12% lactic acid neutralized with ammonium hydroxide. It is available in single 140-gm tubes.

For those on a quest for whiter teeth, Den-Mat Corp., Santa Maria, Calif., offers Rembrandt Plus Whitening Rinse with Peroxide. In addition to whitening teeth and fighting bad breath, the alcohol-free mouthwash helps protect against gingivitis and gum disease. According to the company, significant results are seen within two weeks. For further information, call (800) 433-6628.

A new high-potency oral antioxidant and zinc supplement may help delay the progression to advanced age-related macular degeneration (AMD) in people with intermediate AMD in one or both eyes or those with advanced AMD in one eye. Ocuvite PreserVision, from Bausch & Lomb, Rochester, N.Y., (800) 553-5340, is the same formulation used in a National Eye Institute study demonstrating the value of high-potency vitamin and mineral supplements in age-related eye conditions.

Home Health Care

Par-SORB is a new product available from The Parthenon Co., Salt Lake City, (800) 453-8898. Made especially for ileostomy and colostomy patients, Par-SORB comes in the form of an absorbent gel packet or bulk granules. Placed in the ostomy pouch, the product helps make stomal fluids more manageable by changing them into a gel, thereby preventing leakage, controlling odor, and enhancing the health of peristomal skin.

Etc.

A global licensing agreement between 3M, St. Paul, and the Walt Disney Co., Burbank, Calif., is bringing several new first aid products to store shelves. Nexcare Tattoo Waterproof Bandages sport popular characters from the Disney/Pixar films Monsters Inc. and Toy Story 2. The bandages, resembling real tattoos, seal around the pad to help promote faster healing by blocking out water, dirt, and germs. Nexcare Winnie the Pooh Gentle Paper Bandages offer nine designs in lightweight, breathable material that lets air in and moisture out, and the soft, absorbent pad will not stick to the wound. The bandages will be available at drugstores nationwide at a retail price of $2.79. For ordering information, call (800) 364-3577.

Innovative Swab Technologies, Antioch, Ill., (800) 788-9873, is now offering a convenient single-use dispenser for its line of premoistened snap-open sanitary swabs. Each swab comes with a premoistened tip for precise application of a wide variety of specialty medications.

 

Nancy Jillard. New Product Newswire. Drug Topics 2002;2:69.