FDA modifies extra-label drug use of cephalosporins.
U.S. Food and Drug Administration
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On Jan. 6, 2012, the U.S. Food and Drug Administration (FDA) Center for Veterinary Medicine issued an order that will modify extra-label drug use of cephalosporin antibiotics in cattle. Following a 60-day comment period, the order will mean:
Effective April 5, 2012, veterinarians can continue to prescribe extra-label use of any cephalosporin as long as it is the same dosage, used through the same route of administration and in the same species as its FDA approved label.
The official FDA statement can be found here.
The proposed order does not affect FDA’s approved indications for ceftiofur. You can continue with confidence to prescribe ceftiofur products for FDA-approved uses in cattle. When used according to approved label indications, ceftiofur products are safe and effective in treating diseases while protecting the food supply.
This ruling affects the following Pfizer Animal Health products:
Effective April 5, 2012, veterinarians can continue to prescribe extra-label use of any cephalosporin as long as it is the same dosage, used through the same route of administration and in the same species as its FDA approved label.
The official FDA statement can be found here.
The proposed order does not affect FDA’s approved indications for ceftiofur. You can continue with confidence to prescribe ceftiofur products for FDA-approved uses in cattle. When used according to approved label indications, ceftiofur products are safe and effective in treating diseases while protecting the food supply.
This ruling affects the following Pfizer Animal Health products:
- EXCEDE® (ceftiofur crystalline free acid) Sterile Suspension
- EXCENEL® RTU (ceftiofur hydrochloride) Sterile Suspension
- NAXCEL® (ceftiofur sodium) Sterile Powder
- SPECTRAMAST® LC (ceftiofur hydrochloride) Sterile Suspension
- SPECTRAMAST® DC (ceftiofur hydrochloride) Sterile Suspension
As you review the new ruling and consider how it impacts your clients, know we are here to help. Your Pfizer Animal Health representative can answer any questions that you or your producer clients may have.
If you have additional questions about this ruling, please contact your Pfizer Animal Health representative or VMIPS (Veterinary Medical Information and Product Support) at (855) 4AH-PFIZER (855-424-7349).
Pfizer Animal Health firmly believes the interests of animal health and human health are best served when veterinarians have the flexibility and discretion to select the appropriate medication to effectively treat diagnosed illnesses in animals.
Pfizer Animal Health is committed to ensuring a safe, sustainable food supply from healthy beef and dairy cattle, swine and poultry.
If you have additional questions about this ruling, please contact your Pfizer Animal Health representative or VMIPS (Veterinary Medical Information and Product Support) at (855) 4AH-PFIZER (855-424-7349).
Pfizer Animal Health firmly believes the interests of animal health and human health are best served when veterinarians have the flexibility and discretion to select the appropriate medication to effectively treat diagnosed illnesses in animals.
Pfizer Animal Health is committed to ensuring a safe, sustainable food supply from healthy beef and dairy cattle, swine and poultry.
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