# New Animal Drugs; Bc6 Recombinant Deoxyribonucleic Acid Construct
> **Food and Drug Administration** · Final rule. · Published 2009-02-11 · Effective 2009-02-11 · 74 FR 6823
## Document
- **Document number:** E9-2881
- **Category:** other
- **Sub-agency:** Food and Drug Administration
- **Federal Register citation:** 74 FR 6823
- **CFR reference:** 21 CFR 510
- **Publication date:** 2009-02-11
- **Effective date:** 2009-02-11
- **HHS docket:** Docket No. FDA-2009-N-0665
## Abstract

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect the original approval of a new animal drug application (NADA) filed by GTC Biotherapeutics, Inc. The NADA provides for use of a recombinant deoxyribonucleic acid (rDNA) construct in a lineage of genetically engineered (GE) goats expressing recombinant human antithrombin in their milk. The subsequently purified antithrombin is a biological product for human therapeutic use. In a separate action, a biologics license application (BLA) has been approved by FDA for use of this antithrombin in humans.

## Source
- [Federal Register document](https://www.federalregister.gov/documents/2009/02/11/E9-2881/new-animal-drugs-bc6-recombinant-deoxyribonucleic-acid-construct)
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