Conjugated estrogens Federal Register notice to seek comments on delta-8,9 DHES component.
Executive Summary
FDA CONJUGATED ESTROGENS FEDERAL REGISTER NOTICE PLANNED for the coming weeks to solicit further comment on whether delta-8,9 dehydroestrone (DHES) should be required as a component of generic conjugated estrogen products, as maintained by the innovator company Wyeth-Ayerst (Premarin). The notice will be followed by a 30-day comment period, the generic drug company Duramed said Oct. 30. Duramed has an ANDA pending for conjugated estrogens that does not contain delta-8,9 DHES.