New FDA Approvals
New FDA Approvals
These drugs and/or new indications have received final approval from the U.S. Food and Drug Administration:
- New indication for osteoporosis treatment Fosamax (alendronate sodium) by Merck. The new indication is specifically for the treatment of glucocorticoid-induced osteoporosis in men and women. For patients taking glucocorticoids (corticosteroids or steroids) in a daily dosage equivalent to 7.5 mg or more of prednisone and have low bone mineral density (BMD), the new indication allows for treatment to increase BMD of the hip and spine and to prevent spine fractures.
The new indication follows a two-year study of the drug’s newly indicated properties. The drug already is indicated for osteoporosis prevention and treatment for postmenopausal women and for the treatment of Paget’s disease. The recommended dosage accompanying the new indication is 5 mg once daily for the treatment of low BMD in men and women on glucocorticoid therapy, and 10 mg daily for low BMD in postmenopausal women receiving glucocorticoids but not taking estrogen.
- Patient-expansion approval for epilepsy treatment Topamax (topiramate) by Ortho-McNeil. The approval allows the drug’s use in pediatric patients ages 2 to 16, as a treatment for uncontrolled partial seizures. The drug was approved for adult patients in 1996.
- Reformulation of diabetes treatment Velosulin (recombinant DNA human buffered origin) by Novo Nordisk. The new formulation, structurally identical to insulin produced in the pancreas, replaces the semi-synthetic formulation of Velosulin available since 1986. The drug is indicated for use in external infusion pumps or by administration in U-100 insulin syringes.
- Anticoagulant Warfarin Sodium tablets, by Taro Pharmaceuticals as the generic equivalent to DuPont’s Coumadin. Approval includes the marketing of the tablets in nine dosages commonly prescribed (1 mg, 2 mg, 2.5 mg, 3 mg, 4 mg, 5 mg, 6 mg, 7.5 mg and 10 mg).
- Topical corticosteroid Fluocinonide Ointment 0.05%, by Taro Pharmaceuticals. Indicated for relief of inflammatory and pruritic manifestations of corticosteroid dermatosis, the drug is the generic equivalent of Medicis’ Lidex.
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