Animal & Veterinary
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Bovine Somatotropin (BST)
Bovine somatotropin (bST) is an animal drug approved by FDA to increase milk production in dairy cows. This drug is based on the growth hormone naturally produced in cattle. Growth hormone is a protein hormone produced in the pituitary gland of animals, including humans, and is essential for normal growth, development, and health maintenance. In the 1980s it became technically possible and economically feasible to produce large quantities of bST by a process using biotechnology.
FDA approved a bST product in 1993 after determining that its use would be safe and effective. Part of FDA’s safety evaluation was to ensure that milk from treated cows was safe for human food.
For more information about bST, see the following references.
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Report
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CVM Updates
- April 21, 2000
FDA Responds to Citizen Petition on BST - April 13, 1999
FDA Analysis of DGXXIV Report on Public Health Aspects of BST - February 05, 1999
Update on Human Food Safety of BST - January 14, 1999
Update on Bovine Somatotropin - December 18, 1996
VMAC Endorses Post-Approval Monitoring Program for Posilac® - May 16, 1996
Two Year Report On BST
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Freedom of Information Summary
NADA 140-872 POSILAC® (sterile sometribove zinc suspension) - original approval (PDF - 814KB)- NADA 140-872 Posilac 1 Step® - 2001 supplemental approval (PDF - 231KB)
- NADA 140-872 Posilac 1 Step® - 2003 supplemental approval (PDF - 496KB)
NADA 140-872 - FONSI - Posilac® Sterile Injectable for Cattle (PDF - 611KB)NADA 140-872 - EA - Posilac® Sterile Injectable for Cattle (PDF - 4.1MB)
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