Just one
pre-measured dose
Supplied in ready-to-use
dropperettes
Effective for
up to 30 days
No at-home
applications needed
Does not
require refrigeration
Simplera is a generic that is FDA-approved to be bioequivalent to Claro® (florfenicol, terbinafine, mometasone furoate) Otic Solution
Simplera is an affordable, pre-measured, single-dose treatment that’s effective for the most common cases of canine otitis externa.
YES. Simplera was approved by the FDA as bioequivalent to Claro in September 2022 as part of abbreviated new animal drug application (ANADA) # 200-719.
Simplera is effective for up to 30 days, giving dogs lasting relief in just one dose.
Yes, SIMPLERA is indicated for the treatment of otitis externa in dogs associated with susceptible strains of yeast (Malassezia pachydermatis) and bacteria (Staphylococcus pseudintermedius).
To obtain FDA approval, a generic veterinary medication is required to contain the same active ingredient, in the same concentration, dosage form, and route of administration as the original animal drug.4
Simplera is considered fully bioequivalent by the FDA because it contains:
Simplera contains the same active ingredients in the same concentrations as the active ingredients in Claro: 16.6 mg/mL florfenicol, 14.8 mg/mL terbinafine (equivalent to 16.6 mg/mL terbinafine hydrochloride) and 2.2 mg/mL mometasone furoate.
As a requirement for FDA approval, Vetoquinol had to demonstrate that Simplera contains the same active ingredients in the same concentrations and dosage as Claro and that it contains no inactive ingredients that may significantly affect the bioavailability of the active ingredients. For this reason, you can be confident you will achieve the same results with Simplera.
Simplera should be administered by veterinary personnel.
| Simplera | Claro5 |
Osurnia® (florfenicol, terbinafine, betamethasone acetate)6 |
Mometamax Single™ (gentamicin, posaconazole, and mometasone furoate otic suspension)7 |
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Treats otitis |
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Pre-filled and |
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Single-dose efficacy |
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Long shelf life |
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Helps minimize |
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No risk of |
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Cost per dose |
$ |
$$ |
$ |
$$$$ |
Complete this form to request more information about Simplera. Contact your Vetoquinol Territory Manager or preferred distributor to order.
IMPORTANT SAFETY INFORMATION:
CAUTION: Federal (U.S.A.) law restricts this drug to use by or on the order of a licensed veterinarian. WARNINGS: Not for use in humans. Keep this and all drugs out of reach of children. Do not use in cats. In case of accidental skin contact, wash area thoroughly with water. Avoid contact with eyes. Humans with known hypersensitivity to florfenicol, terbinafine hydrochloride or mometasone furoate should not handle this product. PRECAUTIONS: Do not administer orally. Do not use in dogs with known tympanic membrane perforation. Reevaluate the dog if hearing loss or signs of vestibular dysfunction are observed during treatment. Use of topical otic corticosteroids has been associated with adrenocortical suppression and iatrogenic hyperadrenocorticism in dogs (see ANIMAL SAFETY on label). Use with caution in dogs with impaired hepatic function (see ANIMAL SAFETY on label). The safe use of Simplera in dogs used for breeding purposes, during pregnancy, or in lactating bitches has not been evaluated. For full prescribing information, see below or visit www.vetoquinolusa.com/simplera-info.
INDICATION:
Simplera™ is indicated for the treatment of otitis externa in dogs associated with susceptible strains of yeast (Malassezia pachydermatis) and bacteria (Staphylococcus pseudintermedius).
REFERENCES: