Zdrowie i gospodarka · 22/08/2018

FDA Clears DANOCRINE (Danazol) Capsules for Sale, Except for Fibrocystic Breast Disease Indication

The US Food and Drug Administration (FDA) has ruled that DANOCRINE (danazol) capsules in doses of 50mg, 100mg, and 200mg were not withdrawn from sale due to safety or effectiveness concerns, except for the indication of fibrocystic breast disease, which was withdrawn for the same reasons. The FDA will continue to approve Abbreviated New Drug Applications (ANDAs) for this drug as long as they comply with relevant regulations.