YES. Simplera was approved by the FDA as bioequivalent to Claro in July 2022 as part of abbreviated new animal drug application (ANADA) # 200-719.
In short, according to the FDA, a product that is approved as “bioequivalent” is considered the same as the pioneer product, in this case, Claro® Otic Solution. As a bioequivalent, topically applied solution intended for local therapeutic effect, the FDA did not require Vetoquinol to conduct new in vivo studies of Simplera.
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.
Please complete this form to request more information about Simplera (florenicol, terbinafine, mometasone furoate) Otic Solution.
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: