Determination That DANOCRINE (Danazol) Capsules, 50 Milligrams, 100 Milligrams, and 200 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness Except the Indication of Fibrocystic Breast Disease, Which Was Withdrawn From Sale for Reasons of Safety or Effectiveness

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The Food and Drug Administration (FDA or Agency) has determined that DANOCRINE (danazol) Capsules, 50 milligrams (mg), 100 mg, and 200 mg, were not withdrawn from sale for reasons of safety or effectiveness, except with respect to the indication of fibrocystic breast disease that was withdrawn for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to suspend approval of abbreviated new drug applications (ANDAs) that refer to this drug product and have removed the indication for fibrocystic breast disease. This determination also will allow FDA to continue to approve ANDAs that refer to this drug as long as they meet relevant legal and regulatory requirements. However, the Agency will not accept or approve ANDAs for DANOCRINE (danazol) Capsules, 50 mg, 100 mg, and 200 mg that include fibrocystic breast disease as an indication.