New product newswire

RxNEW DRUGS The FDA has approved Balacet 325 (100 mg propoxyphene napsylate/325 mg acetaminophen) tablets (CIV) for the treatment of mild to moderate pain in patients aged 18 years and older. The medication contains the lowest dose of acetaminophen available in a propoxyphene/acetaminophen combination, thus helping to reduce the risk of acetaminophen toxicity. For further information, call Cornerstone BioPharma, Cary, N.C., (888) 466-6503.

NEW INDICATIONS Switzerland-based Vifor International Ltd. has FDA approval for a new indication for Venofer (iron sucrose injection, USP). The injectable solution can now be used for the treatment of iron deficiency anemia in patients with chronic kidney disease who are not undergoing dialysis. The medication received U.S. approval earlier for treating iron deficiency anemia in patients undergoing chronic hemodialysis on supplemental erythropoietin therpy. The licensed partner for Venofer in the United States is American Regent, Shirley, N.Y., (631) 924-4000.

Alinia (nitazoxanide) tablets (500 mg) and oral suspension (100 mg/5 mL) are now available for the treatment of diarrhea caused by Cryptosporidium parvum infection in adults and children 12 years of age and older. The product, from Romark Laboratories, Tampa, Fla., (813) 282-8544, was already approved as a treatment for the same infection in younger children.

Ivax Pharmaceuticals, Miami, Fla., (305) 575-6000, will begin distributing oxycodone HCl controlled-release tablets (C-II) in the United States. The narcotic is indicated for the management of moderate to severe pain for patients who need continuous analgesia. Available in 10-, 20-, 40-, and 80-mg dosage strengths, it is a generic equivalent to OxyContin, from Purdue Pharma.

Keflex is being offered to customers once again-this time as Keflex Powder for Oral Suspension (cephalexin USP). Advancis Pharmaceutical Corp., Germantown, Md., (301) 944-6600, is making the cephalosporin antibiotic available for the treatment of respiratory tract infections, otitis media, skin and skin structure infections, bone infections, and genitourinary tract infections. Customary dosing is 25-50 mg per kg of patient weight per day, in divided doses. The product comes in strengths of 125 mg/5 mL and 250 mg/5 mL in 100- and 200-mL bottles.

Hi-Tech Pharmacal, Amityville, N.Y., (631) 789-8228, is introducing a generic version of GlaxoSmith-Kline's Zovirax suspension in a 200 mg/5 mL concentration. Acyclovir oral suspension is indicated for the treatment of herpes zoster infections, genital herpes, and chicken pox.

Alpharma Inc., Fort Lee, N.J., (201) 947-7774, has been granted final approval for glyburide/metformin HCl tablets in strengths of 1.25 mg/250 mg; 2.5 mg/500 mg; and 5 mg/500 mg. The product is indicated as an adjunct to diet and exercise in the treatment of Type 2 diabetes. It provides a generic alternative to Bristol-Myers Squibb's Glucovance.

Eon Laboratories, Lake Success, N.Y., (516) 478-9700, holds final approval for bupropion HCl ER 200-mg tablets, a generic alternative to GlaxoSmithKline's Wellbutrin SR 200-mg tablets. Bupropion is indicated for the treatment of major depressive disorder.

Adding to its unit-dose line, American Health Packaging, Columbus, Ohio, (800) 707-4621, is introducing three more items. Clonidine tablets, in 0.1-, 0.2-, and 0.3-mg strengths, are AB-rated to Catapres, from Boehringer Ingelheim, and are indicated for use in the treatment of hypertension. Hydrochlorothiazide tablets, in 25 and 50 mg, a diuretic and antihypertensive, is AB-rated to Merck's Hydrodiuril. Metoclopramide tablets are AB-rated to A. H. Robins' Reglan. The drug is indicated for treatment of symptomatic gastroesophageal reflux and diabetic gastroparesis, the prevention of nausea and vomiting associated with emetogenic cancer chemotherapy, the prevention of postoperative nausea and vomiting, and for facilitating small bowel intubation and radiologic examination. All medications are available in 100 count.

OTC Paglieri Mugnosa USA, Yonkers, N.Y., (914) 779-7470, is introducing a line of flavored oral care products. Eight Fructodent Gourmet Toothpastes have been formulated with natural extracts to address various aspects of dental care. Packaged in stand-up dispensers are: Green Apple Cavity Protection Gel; Orange & Lemon Tartar Control Toothpaste with Vitamin C; Mint & Chocolate Total Protection Gel; Mint & Strawberry Plaque Prevention Gel; Eucalyptus, Aniseed, and Licorice Breath Freshening Gel; Lemon & Sage Whitening Toothpaste with Vitamin C; Mint & Licorice Whitening Toothpaste for Smokers with Vitamin C; and Vanilla Whitening Toothpaste for Tea and Coffee Drinkers with Vitamin C.

Reese Pharmaceutical Co., Cleveland, (216) 231-6441, has strengthened the formulations on two of its liquid cough-relief products. Double Tussin DM Intense Cough Reliever now contains 300 mg of guaifenesin and 20 mg of dextromethorphan per 5 mL. In addition, the company has reformulated its Theracof Plus Multi-Symptom Cough and Cold Reliever, which now contains 650 mg acetaminophen, 200 mg guaifenesin, 20 mg dextromethorphan, and 10 mg phenylephrine in each 10-mL adult dose.

An easier way to quit smoking is now available in the new NicoDerm CQ ThinFlex patch. Slimmed down and more flexible than its predecessor, the ThinFlex patch moves with the wearer-walking, running, stretching, and swimming. And the new design, according to GlaxoSmithKline Consumer Healthcare, Pittsburgh, makes the patch less visible and therefore more conducive to quitting smoking. For further information, call (888) 825-5249.

Zestra, a topically applied hormone-free sexual arousal solution for women, is expanding from on-line-sales-only status to full nationwide distribution through retail pharmacies. Zestra, from Qualilife Pharmaceuticals, Charleston, S.C., (877) 493-7872, is a blend of botanical ingredients, including borage seed oil, evening primrose oil, angelica extract, coleus extract, and vitamins C and E.

Senokot Brand Wheat Bran is a fiber supplement made with 100% wheat bran. A product of Purdue Pharma, Stamford, Conn., (203) 588-5000, this wheat bran powder formulation is grit-free, mixes in an eight-oz. glass of water, and won't gel after it is stirred. Three flavors are available: orange, orange flavor sugar-free, and flavor-free sugar-free. Recommended dosing is from one to three scoops per day; each scoop provides three grams of dietary fiber.

Matrixx Initiatives, Phoenix, is offering several additions to its Zicam product line. Four new Zicam flu-relief products (Cold & Flu Day, Cold & Flu Nite, Maximum Strength Flu Day, and Maximum Strength Flu Nite) are packaged and dosed with the Redi-Dose delivery spoon. The flavorless medication dissolves in any hot or cold beverage. Matrixx is also adding Zicam Cough Mist Max to its cough mist line, providing extended, non-drowsy cough relief for up to eight hours. For further information, call (877) 942-2626.

HEE Corp., Hutchinson, Kan., (620) 663-3333, has acquired a natural oral chelate, a detoxifying agent with the potential to inhibit and repair the damaging effects of heart disease. HPB-Artery Klenz is said to have the ability to remove calcium and plaque deposits from blood vessels and improve metabolic and circulatory functions, thereby offering a preventive solution to cardiovascular dysfunction.

Lifeline Therapeutics, Denver, is introducing Protandim, an antioxidant therapy. This dietary supplement increases the production of two key enzymes that help reduce or eliminate the oxidative damage that accompanies the aging process: superoxide dismutase and catalase. In addition, it induces the body to produce antioxidants inside body cells to help destroy free radicals without being consumed themselves. Further information is available at (877) 682-6346.

A new daily throat spray cleans and freshens the throat as it kills airborne germs and bacteria. Antiseptic SinoFresh is alcohol- and sugar-free. From SinoFresh HealthCare, Englewood, Fla., (941) 681-3100, it is available in a mint flavor and is suitable for persons with diabetes.

ALCiS Health, San Jose, Calif., (866) 252-4747, is making available ALCiS Daily Relief, a topical pain cream for relief from muscle and joint pain, including arthritis, backache, strains, sprains, and bruises. Liposomal technology delivers microscopic time-release capsules of active pain-relief ingredients deep into the skin, where relief begins within minutes. The cream is greaseless, nonirritating, and has a pleasant scent.