New drugs, generics, dosages and indications
Full approval has been granted to Genzyme Corp., Cambridge, Mass., (617) 252-7500, for single-agent Campath (alemtuzumab), which was granted accelerated approval in 2001. The indication has also been expanded to include first-line treatment of B-cell chronic lymphocytic leukemia.
ImClone Systems, New York City, (212) 645-1405, and Bristol-Myers Squibb, Princeton, N.J., (609) 252-4000, have received an expanded colorectal cancer indication for Erbitux (cetuximab) to include cetuximab as a single agent in patients with EGFR-expressing, metastatic colorectal cancer after failure of both irinotecan-and oxaliplatin-based regimens.
Taxotere (docetaxel) Injection Concentrate, 20 mg and 80 mg, from Sanofi-aventis, now carries a new indication: for use in combination with cisplatin and 5-fluorouracil for the induction treatment of patients with locally advanced squamous cell carcinoma of the head and neck. The company, located in Bridgewater, N.J., can be reached at (908) 243-6000.
NEW DOSAGE FORM
Lamisil Oral Granules (terbinafine hydrochloride), a product of Novartis Pharmaceuticals, East Hanover, N.J., (862) 778-8300, have been approved for pediatric treatment of scalp ringworm. This new formulation should be sprinkled on food once a day for six weeks, with the actual dosage amount dependent on the weight of the child. Lamisil was approved earlier for treating onychomycosis of the toenails or fingernails.
Two companies have received approval from the FDA for ciclopirox topical solution, 8% (nail lacquer) for the treatment of onychomycosis, a fungal infection of the fingernails and toenails. Approved as a therapeutic equivalent to Sanofi-aventis' Penlac Nail Lacquer, it will be manufactured and marketed by Perrigo Co., Allegan, Mich., (800) 719-9260, and by Taro Pharmaceutical Industries, Hawthorne, N.Y., (888)-TARO-USA.
Two companies have been given approval to manufacture and market clarithromycin for oral suspension: Sandoz, Princeton, N.J., (609) 627-8500, and Ranbaxy Pharmaceuticals, Princeton, (609) 720-9200. The macrolide antibiotic, a generic alternative to Abbott Laboratories' Biaxin, is available in strengths of 125 mg/5 mL and 250 mg/5 mL to treat a variety of bacterial infections.
Toward a healthier diet and lifestyle, the EatSmart Nutrition Scale provides nutrition information for any portion size of up to 1,000 different foods programmed into it. Developed by a pharmacist and targeted mainly to the cardiovascular patient, the scale helps the user to understand nutrition and to make careful food choices to lower blood pressure, control weight, and balance daily nutrient intake. It calculates 12 cardiovascular nutrients: calories, carbohydrates, fiber, sodium, potassium, magnesium, total fat, saturated fat, cholesterol, calcium, protein, and vitamin K. It can also calculate nutrients for any food with a Nutrition Facts label. The product is distributed by Health Tools LLC. For further information, call (201) 327-5425 or log in to http://www.eatsmartproducts.com/.