NEW PRODUCT NEWSWIRE

Rx

NEW DRUGS

Integrity Pharmaceutical Corp., Fishers, Ind., (317) 558-2820, has a prenatal prescription vitamin formulated for optimal nutrition with minimal side effects. Distributed under the StuartNatal label, Duet is available in tablet and chewable forms. Its 29 mg of iron are delivered in a blend said to be easy on the stomach, and its 25 mg of vitamin B₆ help reduce the severity of nausea during pregnancy.

Synthon Pharmaceuticals, Chapel Hill, N.C., (919) 304-4449, has been given FDA's tentative approval for Asimia (paroxetine mesylate) tablets. The antidepressant is used in the treatment of major depressive, obsessive compulsive, and panic disorders.

NEW INDICATIONS

Diovan (valsartan), the angiotensin II receptor blocker from Novartis, East Hanover, N.J., (973) 781-8300, has been given a new FDA-approved indication beyond control of hypertension: the treatment of heart failure in patients intolerant to ACE inhibitors. It is the first drug in its class to be so approved.

NEW GENERICS

Geneva Pharmaceuticals, Broomfield, Colo., (303) 438-4495, claims to have the first generic launch of amoxicillin/clavulanate potassium, providing an alternative to GlaxoSmithKline's Augmentin. The approval includes film-coated tablets, chewable tablets, and powder for oral suspension. The oral antibiotic is indicated for treatment of lower respiratory tract infections, otitis media, sinusitis, skin and skin structure infections, and urinary tract infections

The FDA has given Bioniche Life Sciences, Belleville, Ontario, (416) 815-0700, the OK to market edetate disodium injection (EDTA) in the United States. Approval of EDTA provides a generic alternative to Endrate, from Abbott Laboratories. The drug is indicated for emergency treatment of hypercalcemia and arrhythmia management.

Able Laboratories, Cincinnati, (888) 826-ABLE, has FDA approval for acetaminophen and codeine phosphate tablets USP 300 mg/30 mg and 300 mg/60 mg. The products, representing generic equivalents to Tylenol with Codeine #3 and Tylenol with Codeine #4, respectively, from R. W. Johnson, are used in the treatment of severe pain.

For the treatment of tinea pedis, tinea crusis, and tinea corpus, betamethasone dipropionate and clotrimazole cream has been approved for Alpharma USPD, a subsidiary of Alpharma Inc., Fort Lee, N.J., (201) 947-7774. The antifungal/corticosteroid cream offers a generic alternative to Lotrisone, from Schering-Plough.

NEW DISTRIBUTION

Pharmion Corp., Boulder, Colo., (720) 564-9100, has acquired exclusive U.S. marketing rights to Innohep (tinzaparin sodium injection), from LEO Pharma of Denmark. The once-daily low molecular weight heparin was FDA-approved in 2000 and launched by DuPont Pharmaceuticals. With Bristol-Myers Squibb's acquisition of DuPont, rights to Innohep were returned to LEO. The drug is used in the treatment of acute symptomatic deep vein thrombosis with or without pulmonary embolism when administered in conjunction with warfarin sodium in hospitalized patients.

OTC

Now there is a premeasured powdered calcium supplement, available in single-serve packets--#151;with or without vitamin D. Cal-100, from United Nutrition Products, Greenwich, R.I., (877) 999-4664, provides 1000 mg of elemental calcium in a single packet of grit-free powder that the company claims can be dispersed into any beverage and most foods. The vitamin D version provides 400 IU (100% of the RDA) of vitamin D in each packet.

For men at risk for recurrent colon cancer, Wyeth Consumer Healthcare, Madison, N.J., (800) 282-8805, has introduced Caltrate Colon Health. The product is formulated with 400 IU of vitamin D and 3 gm of calcium carbonate (1200 mg of elemental calcium), the dose of calcium that, according to a New England Journal of Medicine study, helps reduce the risk of recurrent colorectal adenomas. Two tablets daily can protect both the colon and the bones.

 

Nancy Jillard. New Product Newswire. Drug Topics 2002;17:54.