ChemLifeIntelCHEMICAL & LIFE SCIENCES INTELLIGENCE
Access

XTORO

TRACKED

CASHSN
THERAPEUTIC AREAS
MOLECULE INTELLIGENCE SNAPSHOTlive
0
Manufacturers monitored
1
Intelligence briefs
0
Active regulatory actions
0
HSN codes

INTELLIGENCE

Showing 1 of 1 briefs for XTORO
CLINICAL & PIPELINE·Drug Approval

FDA Approves Labeling Supplements for Fonseca Biosciences' XTORO (FINAFLOXACIN)

Fonseca Biosciences has secured FDA approval for two labeling supplements (SUPPL 4 and SUPPL 6) for its New Molecular Entity, XTORO (FINAFLOXACIN 0.3% otic suspension), on March 18, 2026. This regulatory update for the quinolone antimicrobial, originally approved in 2014, impacts commercial strategy, regulatory compliance, and supply chain management for stakeholders in the global chemical and life sciences industry.

90-Day Activity
MKMeera Krishnan· Senior Regulatory Intelligence Analyst
2026-03-18