New product newswire: October 23, 2006

NEW DRUGS

Glumetza (metformin hydrochloride extended-release tablet) is now available from King Pharmaceuticals, Bristol, Tenn., (423) 989-2000, and Depomed Inc., Menlo Park, Calif., (650) 462-5900. It offers once-daily oral dosing for adults with Type 2 diabetes. The tablets, manufactured by King, utilize Depomed's AcuForm drug delivery technology to provide controlled and prolonged release of metformin. The drug is indicated for use alone or in combination with sulfonylurea or insulin as an adjunct to diet and exercise for improved glycemic control.

NEW GENERICS

Lupin Pharmaceuticals, Baltimore, (410) 576-2000, has received FDA approval for ceftriaxone injection 10-gm vials, which provides a generic alternative to Roche's Rocephin. The new size complements the 250-mg, 500-mg, 1-gm, and 2-gm strengths already available. The drug is used to treat a variety of infections caused by susceptible organisms.

Mayne Pharma, Paramus, N.J., (201) 225-5500, has approval for epirubicin hydrochloride for injection as a component of adjuvant therapy in patients with evidence of axillary node tumor involvement after primary breast cancer resection. The drug is available in 50-mg and 200-mg vials.

Mylan Pharmaceuticals, Morgantown, W. Va., (724) 514-1800, a generic arm of Pittsburgh-based Mylan Laboratories, has final FDA approval for topiramate tablets, available in 25-, 100-, and 200-mg strengths. The approval provides a generic version of Topamax Tablets, from Ortho-McNeil, indicated for the treatment of epilepsy and migraine.

KV Pharmaceuticals, St. Louis, (314) 645-6600, will market six new strengths of diltiazem hydrochloride ER capsules through its Ethex subsidiary, also in St. Louis, at (800) 321-1705. The capsules, available in 120-, 180-, 240-, 300-, 360-, and 420-mg strengths, will offer a generic alternative to Forest Laboratories' Tiazac, indicated for the treatment of hypertension and chronic stable angina.

Ranbaxy Pharmaceuticals, Princeton, N.J., (609) 720-9200, will manufacture and market loperamide hydrochloride and simethicone tablets, 2 mg/125 mg. The drug is bioequivalent to Imodium Advanced Caplets, in the same strength, from McNeil Consumer & Specialty Pharmaceuticals. The tablets are indicated for controlling symptoms of diarrhea plus bloating, pressure, and cramps.

Iceland-based Actavis, with U.S. headquarters in Cranford, N.J., (800) 432-8534, has begun shipping pilocarpine hydrochloride 7.5-mg tablets marketed under the Actavis label. The drug is the authorized generic of MGI Pharma's Salagen, in the same strength. Actavis is already offering 5-mg tablets. Pilocarpine is used to treat dryness of the mouth and throat caused by a decrease in the amount of saliva that can result from radiation treatment for cancer of the head and neck or in patients with Sjogren's syndrome.