NEW PRODUCT NEWSWIRE

Rx

NEW DRUGS

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.

NEW INDICATIONS

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, N.J., (800) 727-6500.

Prevacid (lansoprazole), from TAP Pharmaceutical Products, Lake Forest, Ill., (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 IU. 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.

NEW PACKAGING

Metadate CD Extended-Release Capsules (CII) (methylphenidate HCl, USP), a once-daily biphasic formulation 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.

NEW GENERICS

Permission has been granted to Bioniche Life Sciences, Belleville, Ontario, (416) 815-0700, as well as to Faulding Pharmaceuticals, Paramus, N.J., (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. Faulding also offers 30-mg and 90-mg strengths, equivalent to Novartis' Aredia.

Hydrocodone bitartrate and acetaminophen tablets, USP, in strengths of 7.5 mg/325 mg, 10 mg/325 mg, and 10 mg/650 mg, have been approved for Able Laboratories, Cincinnati, (888) 826-ABLE. Approval of the drug, which is indicated for the relief of moderate to moderately severe pain, offers an equivalent to Watson's Noroco and Mikart Inc.'s hydrocodone bitartrate and acetaminophen tablets, according to the company.

Approval to manufacture and market generic versions of the two norethindrone-containing, progestin-only oral contraceptives currently available has been given to Barr Laboratories, Pomona, N.Y., (800) BARRLAB. The company will market both products under these trade names: Camila, as the generic version of Watson's NOR-QD, and Errin, as the generic version of Ortho-McNeil Pharmaceutical's Ortho-Micronor.

Genpharm Inc., Toronto, (416) 236-2631, has tentative approval to market omeprazole 10-mg and 20-mg capsules. The drug is a generic version of Prilosec, from AstraZeneca, indicated for the short-term treatment of duodenal ulcers.

Tentative approval for omeprazole delayed-release capsules in 10- and 20-mg strengths has been given to Eon Labs, Laurelton, N.Y., (800) 526-0225. The drug provides an alternative to AstraZeneca's Prilosec.

Eon Labs has also received final approval for famotidine tablets in 10-mg strength. This approval provides a generic alternative to OTC Pepcid, from Johnson & Johnson/Merck.

Hi-Tech Pharmacal, Amityville, N.Y., (631) 789-8228, has tentative FDA approval to market its EQ 5 mg base/5 ml prednisolone sodium phosphate oral solution, a generic equivalent to Celltech's Pediapred Sodium Phosphate Oral Solution. The agent is indicated for the treatment of endocrine, rheumatic, and dermatological disorders and allergic states in adults and children.

OTC

The new 16-hour Nicotrol Step-down Patch is now on the market for smokers trying to beat their cigarette habit. The patch delivers a continuous, controlled dose of nicotine through the skin during the time the smoker is awake and dealing with cigarette cravings, allowing for uninterrupted sleep at night. Three strengths of the patch—15, 10, and 5 mg—gradually reduce the amount of nicotine delivered until the smoker can do without it altogether. The Nicotrol transdermal system is the product of Pharmacia Consumer Healthcare, Peapack, N.J., (908) 901-8000.

PediaMed Pharmaceutical, Florence, Ky., (859) 282-8582, is introducing a number of allergy, cough, and cold products for comprehensive relief of symptoms in infants, children, and adults. Products will include Viravan, Endal, and Accuhist, as well as Klout, a pesticide-free head lice treatment kit.

Home Health Care

BD Consumer Healthcare, Franklin Lakes, N.J., (201) 847-6800, is introducing what it claims to be the shortest insulin pen needle available in the United States. The new BD Ultra-Fine III 5-mm Mini Pen Needle is 38% shorter than the 8-mm needle and 60% shorter than the original 12.7-mm needle. The company claims the needle is more comfortable, eliminates the need to pinch the skin at the injection site, and may help to reduce needle phobia. It is suggested that for the first two weeks of usage patients monitor their glucose levels more closely.

Sunbeam Products, Maitland, Fla., (800) 435-1250, is offering its new Health at Home Mobile Heat Therapy. Air-activated heat therapy wraps work to ease muscle and joint pain in arms, legs, and back. Odorless and greaseless, they help to increase blood flow to the skin, directing more oxygen and nutrients to the site of the pain. Heat is delivered for up to eight hours.

 

Nancy Jillard. New Product Newswire. Drug Topics 2002;22:73.