New Product Newswire

RxNEW DRUGS Approved for the treatment of uncomplicated urinary tract infections, Proquin XR is claimed to be an "improved version" of ciprofloxacin. The quinolone antibiotic offers a slow and steady release of the drug over the course of six hours, avoiding the release of a large quantity of the agent over a shorter period of time and causing fewer incidences of nausea and diarrhea. The maker is Depomed Inc., Menlo Park, Calif., (650) 462-5900.

NEW INDICATIONS AstraZeneca, Wilmington, Del., (800) 236-9933, has FDA approval for a new indication for Merrem IV (meropenem for injection). The antibiotic can now be used to treat adults and children with complicated skin and skin structure infections. It was approved originally as single-agent therapy for intra-abdominal infections and bacterial meningitis.

AstraZeneca's Atacand (candesartan cilexetil) is used to treat heart failure in patients with left ventricular systolic dysfunction (ejection fraction less than or equal to 40%) to reduce cardiovascular death and heart failure hospitalizations. The angiotensin receptor blocker now has an added effect on these outcomes when used with an ACE inhibitor. The addition of Atacand to conventional therapy, including an ACE inhibitor, provides a 15% relative-risk reduction in cardiovascular failure or heart failure hospitalizations.

A ninth new indication has been approved for Remicade (infliximab), from Centocor Inc., Malvern, Pa., (610) 651-6000. The drug was originally approved for Crohn's disease. Remicade (infliximab) can now be used to reduce the signs and symptoms of active arthritis in patients with psoriatic arthritis, an immune-mediated inflammatory disease typically characterized by the joint inflammation of arthritis and the skin lesions of psoriasis.

NEW FORMULATIONS Focalin XR (dexmethylphenidate HCl) extended-release capsules are now available from Novartis Pharmaceuticals, East Hanover, N.J., (862) 778-8300, to treat attention deficit/ hyperactivity disorder (ADHD) in adults, adolescents, and children. The once-daily dosing begins to work quickly to help patients manage the often-difficult symptoms of ADHD. Focalin XR, a Schedule II drug, is available in 5, 10, and 20 mg. Twice-daily Focalin was approved in 2001.

NEW GENERICS Final approval for nitrofurantoin monohydrate/ macrocrystals 100-mg capsules has been granted to Eon Labs and to Ranbaxy Pharmaceuticals, Princeton, N.J., (609) 720-9200. This generic formulation, which offers an alternative to the branded drug Macrobid, from Procter & Gamble, is an anti-infective indicated for the treatment of acute uncomplicated urinary tract infections caused by susceptible bacteria.

Mylan Laboratories, Pittsburgh, (724) 514-1800, has received FDA approval for the hypertension drug quinapril in combination with a diuretic. Quinapril hydrochloride and hydrochlorothiazide tablets, available in 10 mg/12.5 mg, 20 mg/12.5 mg, and 20 mg/25 mg strengths, provide a generic alternative to Pfizer's Accuretic Tablets ... Tentative approval has been granted to Mylan for olanzapine tablets in strengths of 2.5, 5, 7.5, 10, 15, and 20 mg. As a generic version of Eli Lilly's Zyprexa Tablets, olanzapine, a psychotropic agent, is indicated for use in the treatment of patients with schizophrenia and bipolar disorder.

Octreotide acetate injection, from Bedford Laboratories, Bedford, Ohio, (440) 232-3320, offers a generic alternative to Sandostatin, from Novartis. The drug is indicated for reducing blood levels of growth hormone and IGF-1 in acromegaly patients.

Apotex Corp., Weston, Fla., (800) 706-5575, has received final FDA approval for a new generic hypertension drug. Fosinopril tablets, available in 10-, 20-, and 40-mg dosage strengths, provide an alternative to the branded drug Monopril, from Bristol-Myers Squibb.