September 7, 2010

US amends regulations on new approved medicated feed

The US Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of two supplemental new animal drug applications (NADA) filed by Elanco Animal Health, A Division of Eli Lilly & Co.

This rule is effective September 3, 2010.

Elanco Animal Health, a division of Eli Lilly & Co., filed a supplement to NADA 141-225 that provides for use of Opraflexx (ractopamine hydrochloride) and Rumensin (monensin, USP) Type A medicated articles to formulate two-way combination drug Type C medicated feeds for cattle fed in confinement for slaughter.

Elanco Animal Health also filed a supplement to NADA 141-224 including the above mentioned products and Tylan (tylosin phosphate) to formulate three-way combination drug Type C medicated feeds for cattle fed in confinement for slaughter.

The supplemental NADAs provide for administering ractopamine hydrochloride Type C medicated feeds as a top dress on Type C medicated feeds containing monensin, USP, or monensin, USP, and tylosin phosphate to cattle fed in confinement for slaughter as the means by which the two-way or three-way combinations will be created.

Supplemental NADA 141-224 is approved as of June 7, 2010; supplemental NADA 141-225 is approved as of June 17, 2010; and the regulations in 21 CFR 558.500 are amended to reflect the approvals.