FDA Approves Aurora’s Equine Antimicrobial Oral Suspension

Aurora Pharmaceutical is proud to announce the FDA approval of EQUISUL-SDT (sulfadiazine/trimethoprim) suspension, which is FDA approved for the treatment of lower respiratory tract infections in horses caused by S. equi.

Aug. 1, 2013 — Aurora Pharmaceutical is proud to announce the FDA approval of EQUISUL-SDT (sulfadiazine/trimethoprim) suspension. EQUISUL-SDT is FDA approved (NADA 141-360) for the treatment of lower respiratory tract infections in horses caused by susceptible strains of Streptococcus equi subsp. zooepidemicus. EQUISUL-SDT can be obtained through your veterinarian.

Produced using Aurora’s patented drug product formulation, EQUISUL-SDT demonstrated 20% increased bioavailability over an existing paste product in a pharmacokinetic crossover study. EQUISUL-SDT is approved for oral administration at the dosage of 24 mg combined active ingredients per kilogram body weight (10.9 mg/lb.) twice daily for 10 days. EQUISUL-STD can be administered by volume at 2.7 ml per 45.4 kg (2.7 mL/100 lb.) body weight.

In a controlled field efficacy study of EQUISUL-SDT in horses with lower respiratory tract infections caused by Streptococcus equi subsp. zooepidemicus, 59% (66/112) of the horses receiving EQUISUL-SDT were successfully treated, showing complete resolution of clinical symptoms within seven days after completion of treatment. In contrast, only 15% of the negative control horses demonstrated improvement during the same period. Transtracheal wash samples taken before and after treatment indicated complete bacterial clearance of S. equi subsp. zooepidemicus in 66% of the treated horses. The incidences of adverse events associated with EQUISUL-STD treatment during this study were comparable to those seen in the saline control group and were largely self-limiting. Diarrhea was seen in only 1.1% of the horses treated and resolved without treatment.

In a controlled safety study, horses were administered up to five times the recommended dose of EQUISUL-SDT twice daily for 30 consecutive days. While a higher incidence of loose stool was seen in horses treated with the higher dose of EQUISUL-SDT, in all cases, the incidents were self-limiting and resolved without treatment. EQUISUL-SDT is the only sulfadiazine/trimethoprim product for horses to be tested according to modern FDA requirements.

Aurora Pharmaceutical has supply agreements with all major distributors throughout the United States. Veterinarians can check the website for the list and contact information.

The product is available in 900 mL and 135 mL bottles. More information is available through Aurora customer service at 888-215-1256.






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