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New products for prescription drugs, OTC, home health, health and beauty
Perforomist (formoterol fumarate) Inhalation Solution has been approved for Dey, L.P., Napa, Calif., (707) 224-3200. The drug is administered twice daily-morning and evening-for the long-term maintenance treatment of bronchospasm in patients with chronic obstructive pulmonary disease.
Sanofi-Aventis, Bridgewater, N.J., (908) 243-6000, has FDA approval for a new indication for Lovenox (enoxaparin). The drug can now be used for the treatment of acute ST-segment elevation myocardial infarction (STEMI), the most severe type of heart attack. Lovenox was already approved for preventing ischemic complications of unstable angina and non-Q-wave myocardial infarction (MI).
The FDA has approved the use of Fragmin (dalteparin sodium injection) for extended treatment of symptomatic venous thromboembolism (VTE) to reduce the recurrence of VTE in cancer patients. Fragmin, from Eisai Inc., Teaneck, N.J., (201) 692-1100, and Pfizer Inc., New York City, (212) 733-2323, was earlier approved for the prophylaxis of ischemic complications in unstable angina and non-Q-wave MI. It is also used to prevent DVT in hip surgery, abdominal surgery, and for acutely ill patients whose mobility is severely restricted.
Ortho Biotech, Bridgewater, N.J., (800) 325-7504, has been granted a new indication for Doxil (doxorubicin HCl liposome injection). Already approved for the treatment of ovarian cancer and AIDS-related Kaposi's sarcoma, Doxil is now indicated for use in combination with bortezomib for the treatment of patients with multiple myeloma who have not previously received bortezomib (Velcade, Millenium/Johnson & Johnson) and have received at least one prior therapy.
For Impax Laboratories, Hayward, Calif., (510) 476-2000, the FDA has approved alprazolam extended-release tablets in strengths of 0.5-, 1-, 2-, and 3-mg extended-release tablets. This approval offers an alternative to Pharmacia & Upjohn's Xanax XR for the management of anxiety disorder or the short-term relief of symptoms of anxiety.
An extended-release formulation of Seroquel (quetiatiapine fumarate) has been FDA-approved for AstraZeneca, Wilmington, Del., (800) 236-9933. Once-daily Seroquel XR is indicated for adults in the treatment of schizophrenia.