October 01, 2011

 

 Conditional approval guidance available

posted September 14, 2011
 

Since issuing the first conditional approval of a canine-use pharmaceutical, the Food and Drug Administration has drafted guidance for veterinarians on the use of such conditionally approved animal drugs.

The FDA granted in December 2010 conditional approval for Kinavet-CA1, the first veterinary drug given a conditional approval for use in a major species under provisions of the Minor Use and Minor Species Animal Health Act. The action indicates the drug sponsor, AB Science, has provided reasonable assurance that its drug is effective and has proved it is safe, in this case safe for use in treatment of some tumors in dogs. The "CA1" designation in the drug's name indicates it is labeled for its first conditionally approved application.

FDA spokeswoman Laura Alvey said veterinarians can use conditionally approved drugs only for the approved indications, because full effectiveness has not been demonstrated and only a reasonable expectation of effectiveness has been demonstrated for a specific indication. Extralabel use of such drugs is prohibited.

Drugs with conditional approval can be marketed for up to five years as sponsors gather effectiveness data, FDA information states.

Additional information on conditional approvals is available at www.fda.gov/AnimalVeterinary/NewsEvents/FDAVeterinarianNewsletter/ucm252075.htm.