Danazol will be approved when ALL of the following are met:
- The patient has ONE of the following diagnoses:
- The patient has an FDA labeled indication for the requested medication
OR - The patient has an indication that is supported in CMS approved compendia for the requested medication
AND
- The patient has an FDA labeled indication for the requested medication
- The patient does NOT have any FDA labeled contraindications to the requested medication
AND - ONE of the following:
- The patient will NOT be using the requested medication in combination with another androgen or anabolic steroid
OR - The prescriber has provided information in support of therapy with more than one medication
- The patient will NOT be using the requested medication in combination with another androgen or anabolic steroid
Length of Approval: 12 months
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