New Animal Drugs; Bc6 Recombinant Deoxyribonucleic Acid Construct
other · Food and Drug Administration · Rule · Published 2009-02-11 · Effective 2009-02-11 · 74 FR 6823
Document
Document number
E9-2881
Federal Register citation
74 FR 6823
CFR reference
21 CFR 510
Type
Rule
Action
Final rule.
Category
other
Sub-agency
Food and Drug Administration
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.