A new drug from Bristol-Myers Squibb, Princeton, N.J., (609) 252-4000, combines glipizide and metformin hydrochloride in a single tablet, with two FDA-approved indications for Type 2 diabetes. Metaglip is used, along with diet and exercise, as initial therapy for patients whose blood sugar cannot be satisfactorily managed with diet and exercise alone, as well as second-line therapy for patients taking either metformin or a sulfonylurea with a regimen of diet and exercise who require greater glycemic control. Three dosage strengths are available: 2.5 mg/250 mg (glipizide and metformin); 2.5 mg/500 mg; and 5 mg/500 mg.
A clinical study has determined that combination therapy with Prandin (repaglinide), an oral antidiabetic drug, and insulin sensitizers produces significant glycemic improvement. The FDA has now approved a new indication for the drug: combination therapy with rosiglitazone or pioglitazone-both insulin sensitizers-for the treatment of Type 2 diabetes. Prandin, an insulin secretagogue in that it stimulates insulin secretion, was already approved as monotherapy or in combination with metformin, another type of insulin sensitizer. The manufacturer is Novo Nordisk, Princeton, NJ., (800) 727-6500.
Prevacid (lansoprazole), from TAP Pharmaceutical Products, Lake Forest, MIll., (800) 621-1020, now has pediatric approval for the short-term treatment of symptomatic gastroesophageal reflux disease and erosive esophagitis in children ages one to 11. In adults, the proton pump inhibitor, approved earlier, is indicated for the treatment of heartburn and other gastroesophageal conditions.
A pain-free treatment for vitamin B12 deficiency is now on the market for patients with Crohn's disease. Nascobal Gel (cyanocobalamin, USP), from Bothell, Wash.-based Nastech Pharmaceutical Co., (888) 514-5208, is administered intranasally, where the drug is absorbed through blood vessels in the nose. Nascobal was approved in the United States in 1997 for treatment of pernicious anemia.
NEW DOSAGE STRENGTH
Wyeth Pharmaceuticals, (800) 666-7248, is introducing a new vial size for its ReFacto Antihemophilic Factor (Recombinant): 2000 lU. The recombinant factor VIII product was approved in March 2000 as a therapy for hemophilia A. It is indicated for control and prevention of bleeding episodes and surgical prophylaxis in patients with the condition and for short-term routine prophylaxis to reduce the frequency of spontaneous bleeding episodes. According to the company, the recombinant technology and human serum albumin-free formulation has the potential to reduce the risk of viral contamination for hemophilia A patients.
Metadate CD Extended-Release Capsules (CII) (methylphenidate HCI, USP), a once-daily biphasic formutation of methylphenidate indicated for the treatment of ADHD in patients six years of age and older, are now available in unit-dose packaging. Bar codes are displayed on each unit-dose blister, according to the manufacturer, Celltech Pharmaceuticals, Rochester, N.Y., (716) 475-9000.
Permission has been granted to Bioniche Life Sciences, Belleville, Ontario, (416) 815-0700, as well as to Faulding Pharmaceuticals, Paramus, NJ., (201) 225-5500, to sell the cardiology drug amiodarone hydrochloride injection IV, 150 mg/3 ml, in the United States. The drug is used to initiate treatment, and to prevent frequently recurring ventricular fibrillation and hemodynamically unstable ventricular tachycardia in patients unresponsive to other therapies. This approval provides a generic alternative to Wyeth's Cordarone.
Faulding has also received FDA approval for a 60 mg/10 ml dosage of pamidronate disodium solution. The drug is indicated for treating the hypercalcemia of malignancy, Paget's disease, and osteolytic bone metastases of breast cancer and multiple myeloma. …