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New FDA Approvals

New FDA Approvals

These drugs have received final approval from the Food and Drug Administration:

  • Antidepressant Effexor XR (venlafaxine HCl) Extended-Release Capsules by Wyeth-Ayerst. The FDA has approved a new label change for venlafaxine extended-release capsules for use as a long-term treatment for generalized anxiety disorder (GAD). This marks the first antidepressant indicated for long-term therapy for GAD.
  • Antihistamine Astelin (azelastine HCl) Nasal Spray by Wallace Laboratories. The FDA has approved its use treatment of seasonal allergic rhinitis in pediatric patients as young as 5 at a dosage of one spray per nostril twice a day (0.55 mg/day). Azelastine nasal spray previously had approval for treatment of patients 12 and older.
  • Asthma agent Advair Diskus (fluticasone propionate and salmeterol inhalation powder) by Glaxo Wellcome. This dual-action medication is the first to be approved for use in the United States for the long-term twice-daily, maintenance treatment of asthma in patients 12 and older. The new inhaler contains an inhaled corticosteroid (fluticasone propionate) to reduce inflammation, and an inhaled long-acting bronchodilator (salmeterol) to help prevent bronchoconstriction. Together, inflammation and bronchoconstriction cause the symptoms of asthma. The combination inhaler is not indicated for the relief of acute bronchospasm.
  • Sulfasalazine delayed-release tablet (Azulfadine EN-tab) by Pharmacia. This sulfasalazine is now approved for the treatment of pediatric patients with polyarticular course juvenile rheumatoid arthritis who have responded inadequately to salicylates or other nonsteroidal anti-inflammatory drugs. MGI Pharma will co-promote the product.