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 antidepressant Prozac (fluoxetine hydrochloride) by Eli Lilly. Allows for use in patients 65 and older, following trials involving 700 patients in double-blind, placebo-controlled studies. Prozac is approved for depression, obsessive-compulsive disorder, bulimia nervosa. It is contraindicated until at least two weeks have passed since discontinuing an MAO inhibitor, and MAO inhibitors are contraindicated for at least five weeks after discontinuation of Prozac.
- New indication for monoclonal antibody Remi cade (infliximab) by Ortho-McNeil/Centocor: For combination use with methotrexate for rheumatoid arthritis therapy for patients failing to respond to methotrexate alone. Approval follows randomized trial of 428 patients receiving IV 30 mg/kg at zero, two, and six weeks, then every eight weeks thereafter. Remicade approved in 1998 for Crohn's disease.
- New formulation of HIV therapy Videx (ddl) by Bristol-Myers Squibb. Nucleoside analogue reverse transcriptase inhibitor (NRTI) approved as once-daily dosage consisting of two 200 mg tablets taken together. Videx originally approved for HIV therapy in 1991. Patients should be monitored for pancreatitis, a major adverse effect associated with ddl.
- Estrogen replacement therapy Estropipate tablets by Duramed Pharmaceuticals, as the generic equivalent of Pharmacia and Upjohn's Ogen tablets. Approved to treat moderate to severe vasomotor symptoms of menopause and to prevent osteoporosis. Contraindicated for pregnant patients or those with breast cancer, estrogen-dependent neoplasia, undiagnosed genital bleeding, or active thrombophlebitis.
- Gastric proton-pump inhibitor Aciphex (rabeprazole sodium) by Janssen Pharmaceutical/Eisai. For use in healing of duodenal ulcers, erosive or ulcerative gastroesophageal reflux disease (GERD), and treatment of pathological hypersecretive disorders, including Zollinger-Ellison disease. Dosage recommended: 20 mg oral once daily.
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