regulatory
confidence high
sentiment negative
materiality 0.80
Phibro Animal Health faces FDA actions to revoke Mecadox approval; $20M sales at risk
PHIBRO ANIMAL HEALTH CORP
- FDA issued final order revoking approved method for detecting carbadox residues in swine.
- FDA proposed to withdraw all new animal drug applications for Mecadox in swine feed; Phibro may request hearing.
- Mecadox sales for fiscal year ended June 30, 2023 were approximately $20 million.
- Phibro states it is extremely disappointed, believes in safety, and will defend Mecadox's continued use.
- Company notes 50+ year history of safe use and intends to take appropriate action against FDA's steps.