Pan American Laboratories (PAMLAB, LLC), Mandeville, La., (985) 893-4097, is introducing Metanx tablets, a prescription-only medical food for the dietary management of patients who are under a physician's care for endothelial dysfunction and hyperhomocysteinemia. Each tablet contains 2.8 mg of L-methylfolate, as well as active forms of pyridoxine (vitamin B6) and cobalamin (vitamin B2). Metanx tablets contain no sugar, lactose, yeast, or gluten. The customary dosage is one or two tablets daily.
RxNEW DRUGS Pan American Laboratories (PAMLAB, LLC), Mandeville, La., (985) 893-4097, is introducing Metanx tablets, a prescription-only medical food for the dietary management of patients who are under a physician's care for endothelial dysfunction and hyperhomocysteinemia. Each tablet contains 2.8 mg of L-methylfolate, as well as active forms of pyridoxine (vitamin B6) and cobalamin (vitamin B2). Metanx tablets contain no sugar, lactose, yeast, or gluten. The customary dosage is one or two tablets daily.
Now commercially available is CoTherix's Ventavis (iloprost) Inhalation Solution, indicated for the treatment of pulmonary arterial hypertension (PHA), a potentially fatal disease involving high blood pressure in the pulmonary arteries. Ventavis, FDA-approved in December of last year, is a drug in the prostacyclin class of PAH treatments. CoTherix is based in South San Francisco and can be reached at (650) 808-6500.
Approved in late 2004, Combunox (oxycodone HCl and ibuprofen) tablets, 5 mg/400 mg (CII), are now available from St. Louis-based Forest Laboratories, (800) 678-1605. The opioid/nonsteroidal anti-inflammatory drug combination is indicated for the short-term (up to seven days) management of acute moderate to severe pain, typical of that following surgery or injury.
NEW INDICATIONS Millennium Pharmaceuticals, Cambridge, Mass., (800) 589-9005, has received FDA approval for a new indication for Velcade (bortezomib) for Injection. Already approved for use in patients with multiple myeloma who have had at least two prior therapies and whose disease has progressed since the second therapy, the antineoplastic agent can now be used for multiple myeloma patients after only a single prior therapy.
Following FDA priority review, Schering-Plough, Kenilworth, N.J., (908) 298-4000, received full approval for Temodar (temozolomide) Capsules as well as a new indication for the medication. Temodar can now be used in combination with radiotherapy for the treatment of adult patients with newly diagnosed glioblastoma multiforme (GBM), a form of malignant brain cancer, and then as maintenance treatment following radiotherapy. Concurrent with the approval for newly diagnosed GBM, Temodar received full approval for the treatment of adult patients with refractory anaplastic astrocytoma (AA), another form of brain tumor, at first relapse following treatment with a drug regimen containing a nitrosurea and procarbazamine. Temodar received accelerated approval for the treatment of AA in 1999.
Rx (cont.)NEW FORMULATIONS Once-a-month oral Boniva (ibandronate sodium) 150-mg tablets were approved for Roche Pharmaceuticals, Nutley, N.J., (800) 526-6367, and GlaxoSmithKline, Research Triangle Park, N.C., (919) 483-2100. The bis-phosphonate, approved earlier in a 2.5-mg daily formulation, is indicated for the treatment and prevention of postmenopausal osteoporosis. Patients are to take the new tablet with plain water on an empty stomach and remain upright, avoiding food, drink, and other medications for at least one hour.
Trecator-SC (ethionamide tablets, USA) Sugar-Coated Tablets have been reformulated to film-coated tablets and renamed Trecator. The drug is indicated primarily for the treatment of patients with Mycobacterium tuberculosis resistant to isoniazid or rifampin. However, the new film-coated tablet is more rapidly absorbed, resulting in higher peak concentrations (Cmax) of ethionamide. This could lead to patient intolerance when introduced at the same initial dose as the sugar-coated tablet. Patients should therefore be monitored carefully and have their dosage retitrated when switched from the older tablet to the newly approved one. The maker is Wyeth Pharmaceuticals, Philadelphia, (800) 934-5556.