The Food and Drug Administration, Department Of Health And Human Services, has announced that it is amending the animal drug regulations to reflect approval of a new animal drug application.

Elanco Animal Health filed a new animal drug application that provides for use of TOPMAX 9 (ractopamine hydrochloride) Type A medicated article to make Type B and Type C medicated feeds used for increased rate of weight gain and improved feed efficiency in finishing turkeys.

The application is approved as of 12 November, 2008.

The agency has carefully considered the potential environmental effects of this action, and the FDA has concluded that the action will not have a significant impact on the human environment, and that an environmental impact statement is not required.

This approval qualifies for 3 years of marketing exclusivity beginning on the date of approval.