Drug Criteria & Outcomes: New FDA Approvals
May 1, 2002
Drug Criteria & Outcomes: New FDA Approvals
These drugs recently received final approval from the Food and Drug Administration (FDA):
• Morphine sulfate extended-release by Elan Corp. The FDA has granted marketing approval of morphine sulfate extended-release (Avinza) capsules for the once-daily treatment of chronic, moderate-to-severe pain in patients who require continuous, around-the-clock therapy for an extended period of time.
• Desloratadine (Clarinex) by Schering-Plough. In February 2002, desloratadine tablets were approved for the treatment of perennial allergic rhinitis and for symptomatic relief of chronic idiopathic urticaria in adults and children age 12 and older. Desloratadine, in an oral tablet formulation, was approved for the treatment of seasonal allergic rhinitis in adults and children age 12 and older in December 2001. Desloratadine is a once-daily nonsedating antihistamine that provides 24-hour relief.
• Nitisinone (Orfadin) by Orphan Pharmaceuticals. The FDA has approved Orfadin (nitisinone) capsules for the treatment of hereditary tyrosinemia type I. Orfadin capsules are to be used in conjunction with a diet restricted in tyrosine and phenylalanine.
• Neulasta (pegfilgrastim) by Amgen. Neulasta (pegfilgrastim) is approved as a treatment for patients undergoing chemotherapy, to decrease the incidence of infection by febrile neutropenia. It is administered in a single fixed dose with each cycle of chemotherapy.
• Leuprolide acetate (Eligard) by Atrix Laboratories. The FDA has approved leuprolide acetate (Eligard) 7.5 mg (formerly Leuprogel One-Month Depot) for the treatment of advanced prostate cancer. Eligard (for subcutaneous injection) is designed to deliver 7.5 mg of leuprolide acetate at a controlled rate over a one-month therapeutic period.
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