2016-17501: New Animal Drugs; Change of Sponsor

Summary

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor for 57 approved new animal drug applications (NADAs) and 14 approved abbreviated new animal drug applications (ANADAs) from Elanco Animal Health, A Division of Eli Lilly & Co. to Elanco US, Inc.

The agency’s own summary, as published.

What this changes

Amends 5 parts of the Code of Federal Regulations — the standing rules this notice rewrites.

• 21 CFR 510 New Animal Drugs
• 21 CFR 520 Oral Dosage Form New Animal Drugs
• 21 CFR 522 Implantation or Injectable Dosage Form New Animal Drugs
• 21 CFR 524 Ophthalmic and Topical Dosage Form New Animal Drugs
• 21 CFR 558 New Animal Drugs for Use in Animal Feeds