Human Medications, Human Drugs, Animal Medications, Animal Drugs, Pharmacy law, Pharmaceutical law, Compounding law, Sterile and Non Sterile Compounding 797 Compliance, Veterinary law, Veterinary
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Food and Drug Administration and Compliance Issues
Tuesday, March 24, 2020
FDA Approves First Generic Form of Marbofloxacin, an Antibiotic for Use in Dogs and Cats
The U.S. Food and Drug Administration today approved Marboquin, the first generic approval for marbofloxacin tablets, originally approved as Zeniquin. Marboquin is in tablet form and is intended for the treatment of susceptible infections in dogs and cats.
Marbofloxacin, the active pharmaceutical ingredient in both Marboquin and Zeniquin, is in the fluoroquinolone class of antibiotics. Fluoroquinolones are considered medically important antimicrobials in human medicine. Marboquin, like Zeniquin, is available only by prescription because a veterinarian’s expertise is necessary to determine whether treatment with marbofloxacin is appropriate.
The FDA granted the approval of Marboquin to Dechra Veterinary Products, LLC, of Overland Park, Kansas.