FDA grants emergency authorization for Dectomax for NWS
Zoetis Inc. announced Dectomax/Dectomax-CA1 received conditional approval from the Food and Drug Administration for the 100 milliliter vial size to prevent and treat infestations caused by New World screwworm larvae in cattle and to prevent reinfestation for 21 days.
The approval adds the 100 mL size to previously approved 250 mL and 500 mL vial sizes. According to Zoetis, Dectomax-CA1 remains the only nonprescription product conditionally approved by the FDA for prevention and treatment of NWS infestations in cattle.
The conditional approval applies to beef cattle, female dairy cattle younger than 20 months, pregnant beef cows, newborn calves and bulls. The product is not approved for calves processed for veal or female dairy cattle 20 months and older, except under a recently granted emergency use authorization.
Zoetis also received an FDA emergency use authorization for Dectomax/Dectomax-CA1 in additional species, including dairy cattle, horses, sheep, pigs, and deer.
Authorization rules
Under the authorization, the products may be used for prevention and treatment of infestations caused by Cochliomyia hominivorax larvae, also known as myiasis, in lactating dairy cows, dry dairy cows and replacement dairy heifers 20 months and older. Lactating dairy cows treated under the authorization have a 468-hour milk withdrawal period.
The authorization also allows use for prevention of infestations in swine, sheep excluding lactating sheep, deer and horses 1 year old and older.
The FDA’s Center for Veterinary Medicine said the authorization does not constitute full or conditional approval, but it determined the products may be safe and effective for the listed emergency uses. Zoetis said no animal drugs currently have full FDA approval for NWS myiasis.
“We continue to work with CVM to find product solutions that may be safe and effective for use in additional species,” said Mike Lormore, director of cattle and pork technical services at Zoetis. “The recent conditional approval and emergency use authorization will enable additional producers, veterinarians and animal caretakers to implement prevention and treatment procedures to help protect against New World screwworm.”
Lacey Vilhauer can be reached at 620-227-1871 or [email protected].
