The U.S. Food and Drug Administration today issued an Emergency Use Authorization (EUA) for Dectomax/Dectomax-CA1 (doramectin injection) injectable solution for the prevention and treatment of New World screwworm (NWS) infestations (myiasis) in dairy cattle (lactating dairy cows, dry dairy cows, and replacement dairy heifers 20 months of age and older), except for calves that will be processed for veal. The EUA also authorizes Dectomax/Dectomax-CA1 for the prevention of NWS myiasis in swine, horses at least one year old, sheep except for lactating sheep, and deer.
The FDA has concluded that based on the totality of the scientific evidence available, it is reasonable to believe that Dectomax/Dectomax-CA1 may be effective for the indications in the species described above, and the known and potential benefits of the product outweigh its known and potential risks.
Dectomax/Dectomax-CA1 is a single product with one label to reflect the product has:
- Approval (Dectomax) for the treatment and control of certain nematode and arthropod parasites in cattle and swine;
- Conditional approval (Dectomax-CA1) for NWS indications in beef cattle; and
- EUA (Dectomax/Dectomax-CA1) for NWS indications in dairy cattle, horses, swine, sheep, and deer.
Source : fda.gov