Environmental Assessment for Oxytetracycline Dihydrate Administered to Shrimp for Minor Use Minor Species

NIH RePORTER · FDA · R01 · $209,928 · view on reporter.nih.gov ↗

Abstract

Summary/Abstract PAHC is seeking approval from the U.S. Food and Drug Administration (FDA) Center for Veterinary Medicine (CVM) of Terramycin® 200 for Fish Type A medicated article, containing the active pharmaceutical ingredient (API) oxytetracycline, for use in penaeid shrimp. The proposed indication is for the control of mortality in penaeid shrimp due to necrotizing hepatopancreatits (NHP) associated with Hepatobacter penaei. The work involved will include environmental assessment, conditions of use of the drug, exposure assessment, effects assessment, risk characterization, and conclusions.

Key facts

NIH application ID
10885517
Project number
1R01FD008145-01
Recipient
PHIBRO ANIMAL HEALTH CORPORATION
Principal Investigator
Sean Parker
Activity code
R01
Funding institute
FDA
Fiscal year
2024
Award amount
$209,928
Award type
1
Project period
2024-02-10 → 2027-01-09