New product newswire

RXNEW DRUGS

QLT USA Inc., Fort Collins, Colo., has FDA approval to market Aczone (dapsone) Gel 5%. The aqueous gel offers patients a topical treatment for acne vulgaris.

NEW INDICATIONS

Avelox (moxifloxacin HCl) has been approved for use in adults with complicated skin and skin structure infections caused by methicillin-susceptible Staphylococcus aureus, Escherichia coli, Klebsiella pneumoniae, or Enterobacter cloacae. Avelox, developed by Bayer, is marketed in the United States by Schering-Plough, Kenilworth, N.J., (908) 298-4000.

UCB Pharma, Smyrna, Ga., (800) 477-7877, has received FDA approval for a pediatric indication for Keppra, its antiepilepsy therapy. The drug can now be used as add-on therapy in the treatment of partial-onset seizures in children four years of age and older.

Xeloda (capecitabine), from Roche Pharmaceuticals, Nutley, N.J., (800) 526-6367, has been approved for oral chemotherapy for Dukes' C colon cancer (stage III cancer metastasized to the lymph nodes) following surgery. With Xeloda, colon cancer patients can utilize oral chemotherapy earlier in their treatment, replacing many of the hours of intravenous therapy in a clinic with medication taken at home.

NEW FORMULATIONS

Galderma Laboratories, Fort Worth, (817) 961-5000, is introducing MetroGel 1% Topical Gel. The new formulation incorporates a higher concentration of metronidazole than MetroGel 0.75% and is presented in a new, technologically advanced alcohol-free vehicle for the topical treatment of the inflammatory lesions of rosacea. Once-a-day dosing is recommended.

The FDA has approved Clarinex RediTabs Tablets (desloratadine) in an orally disintegrating formulation. It is indicated for the once-daily treatment of allergy symptoms caused by perennial indoor and seasonal outdoor allergens and chronic idiopathic urticaria in adults and children six years of age and older. It is available in 2.5- and 5-mg doses in a new "tutti frutti" flavor.

Par Pharmaceutical, Woodcliff Lake, N.J., (800) 828-9393, is introducing a concentrated formulation of megestrol acetate oral suspension, an appetite stimulant. Megace ES, Par's first approval for a specialty market, is indicated for the treatment of anorexia, cachexia, or an unexplained, significant weight loss in patients with AIDS. It utilizes Elan's NanoCrystal Techology delivery system to improve the rate of dissolution and bioavailability of the original megestrol acetate oral suspension. The trade name Megace was licensed from Bristol-Myers Squibb. A one-teaspoon dose of Megace ES (625 mg/5 mL) daily is bioequivalent to 800 mg/20 mL of megestrol acetate oral suspension when dosed in a fed state.

NEW GENERICS

TEVA Pharmaceuticals USA, North Wales, Pa., (888) TEVA USA, is introducing clarithromycin tablets USP, 250 and 500 mg. AB rated and bioequivalent to Biaxin Filmtab, from Abbott Laboratories, the drug is indicated for treatment of mild to moderate infections caused by susceptible strains of designated microorganisms and is available in bottles of 60.

Ranbaxy Pharmaceuticals, Princeton, N.J., (609) 720-9200, has approval to manufacture and market metformin hydrochloride extended-release tablets in 750-mg strength. The medication will offer an alternative to Bristol-Myers Squibb's Glucophage XR Extended-release Tablets in the same strength. As monotherapy, the tablets are indicated as an adjunct to diet and exercise to improve glycemic control in patients with Type 2 diabetes in patients 17 years of age and older. With a sulfonylurea or insulin, the medication is used to improve glycemic control in Type 2 diabetes patients in the same age group.

A generic version of DDAVP (desmopressin acetate) Tablets 0.1 and 0.2 mg was approved for Barr Pharmaceuticals, Woodcliff Lake, N.J., (800) 222-0190. Desmopressin acetate tablets are indicated as anti-diuretic replacement therapy in the management of central diabetes insipidus and for the management of the temporary polyuria and polydipsia following head trauma or surgery in the region of the pituitary, as well as for the management of primary nocturnal enuresis.