Magazine article Drug Topics

New Product Newswire

Magazine article Drug Topics

New Product Newswire

Article excerpt

Rx

NEW INDICATIONS

Pravachol (pravastatin sodium) has received approval for a new pediatric indication. A product of Bristol-Myers Squibb, Princeton, N.J., (609) 252-4000, the drug can now be used for young patients eight years and older with heterozygous familial hypercholesterolemia.

Bristol-Myers Squibb's Tequin (gatifloxacin) is now approved for uncomplicated skin and skin structure infections, including abscesses, furuncles, folliculitis, wound infections, and cellulitis due to methicillin-susceptible Staphylococcus aureus and to Streptococcus pyogenes. The approval covers both tablets and injection.

New indications for two medications have been approved for Pfizer Inc., New York City, (800) 438-1985. The cholesterol-lowering medication Lipitor has been approved for treatment of familial hypercholesterolemia in children 10 to 17 years of age. And Zyrtec (cetirizine HCI), an antihistamine, can now be used in infants six months of age and older for seasonal allergic rhinitis, perennial allergic rhinitis, and chronic idiopathic urticaria.

Aciphex, a proton pump inhibitor, has gained FDA approval for use in Helicobacter pylori eradication to reduce the risk of duodenal ulcer recurrence. Aciphex, a product of Eisai Inc., Teaneck, N.J., (201) 2872000, is approved for administration for seven days and is used along with antibiotics.

NEW FORMULATIONS

Biovail Corp., Toronto, (416) 2856000, has received tentative FDA approval for an orally disintegrating formulation of the nonbenzodiazepine hypnotic compound zolpidem. Sold under the brand name of Ambien (Sanofi-Synthelabo), zolpidem is indicated for the short-term treatment of insomnia.

NEW PACKAGING

The FDA has approved a 60-dose configuration of the nitroglycerin spray Nitrolingual Pumpspray (0.4 mg nitroglycerin per spray) for First Horizon Pharmaceutical Corp., Alpharetta, Ga., (770) 442-9707. This new size is smaller and more convenient to carry than the currently available 200-dose bottle. The medication is indicated for acute relief or prevention of chest pain associated with angina pectoris.

NEW GENERICS

Andrx Corp., Fort Lauderdale, Fla., (800) 621-7143, has tentative approval for loratadine rapidly disintegrating tablets, an antihistamine indicated for relief of seasonal allergic rhinitis. This form of loratadine, bioequivalent to ScheringPlough's Claritin Reditabs, disintegrates on the tongue within seconds, with or without water.

For Caraco Pharmaceutical Laboratories, Detroit, (313) 871-8400, comes FDA approval for clozapine, indicated for the treatment of schizophrenia. This approval provides a generic alternative to Clozaril, from Novartis.

SuperGen Inc., Dublin, Calif., (925) 560-0101, is cleared to market Mitoztrex (MitoExtra), a proprietary version of generic mitomycin. The drug is used in the therapy of disseminated adenocarcinoma of the stomach or pancreas in proven combinations with other approved chemotherapeutic agents and as a palliative treatment when other therapies have failed.

East Hanover, N.J.-based Sidmak Laboratories, (800) 922-0547, through a joint venture with Banner Pharmacaps, is introducing ethosuximide, USP, 250-mg soft-gel capsules for the control of absence (petit mal) epilepsy. Approval of the anticonvulsant provides a generic alternative to Zarontin, from Parke-Davis.

Amoxicillin and clavulanate potassium tablets, USP, have been approved in 500 mg/125 mg and 875 mg/125 mg strengths for TEVA USA, North Wales, Pa., (888) TEVA USA. The product, a generic alternative to SmithKlineBeecham's Augmentin tablets, is indicated in the treatment of such conditions as sinusitis, otitis media, lower respiratory tract infections, urinary tract infections, and skin and skin structure infections caused by susceptible strains of a variety of organisms.

Barr Laboratories, Pomona, N.Y., (800) BARR LAB, has approval for flecainide acetate tablets, a generic version of 3M's Tambocor. …

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