FDA Approves First Generic Tilmicosin Phosphate Aqueous Concentrate for Swine
January 25, 2022
The U.S. Food and Drug Administration’s Center for Veterinary Medicine has approved Tilmovet AC, the first generic tilmicosin phosphate aqueous concentrate for oral use in drinking water for swine. Tilmovet AC is approved for the control of: (1) swine respiratory disease associated with Pasteurella multocida and Haemophilus parasuis in groups of swine in buildings where a respiratory disease outbreak is diagnosed and (2) swine respiratory disease associated with Mycoplasma hyopneumoniae in the presence of Porcine Reproductive and Respiratory Syndrome Virus (PRRSV) in groups of swine in buildings where a respiratory disease outbreak is diagnosed.
Tilmovet AC contains the same active ingredient (tilmicosin phosphate) in the same concentration and dosage form as the approved brand name drug product, Pulmotil AC, which was first approved on February 13, 2014. In addition, the FDA determined that Tilmovet AC contains no inactive ingredients that may significantly affect the bioavailability of the active ingredient.
The data submitted in support of the Original Abbreviated New Animal Drug Application demonstrate that Tilmovet AC, when used according to its label, is safe and effective.
As part of our efforts to ensure judicious use of antimicrobials and since tilmicosin phosphate is in a class of antimicrobials that are deemed medically important, Tilmovet AC is only available with a prescription from a licensed veterinarian. A veterinarian’s expertise is required to diagnose swine respiratory disease and to determine whether Tilmovet AC is an appropriate treatment.
The tolerances for residues and withdrawal period established for the approved brand name drug product (Pulmotil AC) also apply to Tilmovet AC. Data demonstrate that residues in food products derived from swine treated with Tilmovet AC will not represent a public health concern when the product is used according to the label.
Tilmovet AC is supplied in 960 mL plastic bottles. It is administered in drinking water for five consecutive days.
Tilmovet AC carries a warning to people administering the product, which notes that exposure to tilmicosin in humans has been associated with chest pain, increased heart rate, dizziness, headache, and nausea. Death has also been reported following ingestion or injection of tilmicosin. People administering tilmicosin products should avoid ingestion and direct skin and eye contact as well as wear protective clothing when administering the product to animals. In case of human exposure, call 1-877-426-7765 and consult a physician immediately.
Tilmovet AC is sponsored by Huvepharma EOOD in Sofia, Bulgaria.
For more information:
Issued by FDA Center for Veterinary Medicine.
For questions, Contact CVM.