New product newswire
Pompe disease is a rare but debilitating inherited disease that severely reduces muscle and respiratory function. Newly FDA-approved with Orphan Drug designation is Myozyme (alglucosidase alfa, rhGAA), from Genzyme Corp., Cambridge, Mass., (617) 252-7500. Myozyme is approved for administration by intravenous infusion of solution into a vein, following clinical trials in infantile-onset patients ranging in age from one month to 3.5 years at the time of the first infusion. A boxed warning as to its potentially life-threatening allergic reactions accompanies the drug.
Nexium (esomeprazole magnesium) Delayed-Release Capsules, containing 20 mg or 40 mg of esomeprazole, have been approved for once-daily use in children ages 12 to 17 for the short-term treatment of gastroesophageal reflux disease (GERD). Nexium is the product of AstraZeneca, Wilmington, Del., (800) 842-9920.
A fifth indication has been approved for Pfizer Inc.'s Genotropin (somatropin [rDNA origin] for injection). The growth hormone therapy can now be used for the long-term treatment of growth failure associated with Turner syndrome in patients whose bones are still capable of growing. Pifzer can be reached in New York City at (800) 438-1985.
Novartis' Diovan HCT (valsartan/hydrochlorothiazide) has received FDA approval in two new higher-dose formulations. The blood pressure medication, already approved in 80/12.5 mg, 160/12.5 mg, and 160/25 mg, is now available in strengths of 320/12.5 mg and 320/25 mg. Novartis Pharmaceuticals is headquartered in East Hanover, N.J., at (862) 778-8300.
A generic version of MGI Pharma's Salagen has been granted FDA approval. Pilocarpine hydrochloride, in 5- and 7.5-mg tablets, is indicated for the treatment of symptoms of dry mouth from salivary gland hypofunction caused by radiotherapy for cancer of the head and neck, and for treating symptoms of dry mouth in patients with Sjogren's syndrome. The maker is Impax Laboratories, Hayward, Calif., (510) 476-2000, which will market the product through Global Pharmaceuticals, Philadelphia, (800) 296-5227.
Used for the relief of occasional constipation, polyethylene glycol 3350 powder for oral solution has been approved for TEVA Pharmaceuticals USA, North Wales, Pa., (888) TEVA USA. This is a white powder for reconstitution, rated bioequivalent to Braintree Laboratories' MiraLax. Each packet contains a 17-gm dose (one scoop). There are 12 packets to a carton.