Pet Medication Innovation Watch

Otiserene®

Otiserene® / marbofloxacin, terbinafine, and dexamethasone otic suspension

Recently FDA-confirmed FDA-confirmed FDA-confirmed

For the treatment of otitis externa associated with susceptible strains of yeast ( Malassezia pachydermatis ) and bacteria ( Staphylococcus pseudintermedius ) in dogs.

FDA-confirmed status means Roxee found public approval or market-status evidence. Ask your veterinarian whether this option applies to your pet.

Veterinary professional?

What this means

Owner summary

This is a public veterinary medicine update Roxee is tracking with source-backed evidence and availability labels.

Do not start, stop, or switch medicine without your veterinarian.
Development-stage products are not shown as available unless FDA approval or marketed evidence is public.
Ask your veterinarian about currently approved options for infection.

Vet view

Technical note

No vet-facing summary has been approved for this innovation record yet.

Regulator: FDA/CVM
Pathway: NADA/ANADA/CNADA
FDA application: 141598

Regulatory timeline

Public stage evidence

Only supported or current stages are highlighted.

1 Early research signal
2 Company-disclosed development
3 FDA-CVM development path disclosed
4 Protocol concurrence disclosed
5 Pivotal study planned
6 Pivotal study recruiting
7 Pivotal study completed
8 Technical section submitted
9 Technical section complete
10 All major technical sections complete
11 Administrative NADA/CNADA submitted
12 FDA approved
13 Conditionally approved
14 Available / marketed

What changed

Latest public update

Date detected: May 19, 2026
Stage: FDA approved
Reason: MIW source adapter refresh

Owner-safe interpretation

Availability

FDA-confirmed status means Roxee found public approval or market-status evidence. Ask your veterinarian whether this option applies to your pet.

Expected availability: FDA approved, launch unclear

Evidence

Source-backed record

1 item shown

Otiserene® FDA recent animal drug approval FDA approval / Animal Drugs @ FDA · Primary source 100/100

Source: FDA Recent Animal Drug Approvals
Observed: May 19, 2026
Supports: FDA approved

For the treatment of otitis externa associated with susceptible strains of yeast ( Malassezia pachydermatis ) and bacteria ( Staphylococcus pseudintermedius ) in dogs.

View source evidence