Glaxo Lanoxin (digoxin) NDA approved for heart failure and atrial fibrillation; label rewritten.
GLAXO WELLCOME LANOXIN (DIGOXIN) NDA APPROVED FOR HEART FAILURE and atrial fibrillation after 61 years on the market; the NDA was approved Sept. 30. An indication for atrial flutter was dropped in the revised labeling for digoxin as recommended by FDA's Cardiovascular & Renal Drugs Advisory Committee at its May 1996 review of digoxin data ("The Pink Sheet" May 13, 1996, p. 17).
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