What are the differences between KBroVet-CA1 (potassium bromide chewable tablets) and the former KBroVet tablets?
The two products are labeled differently due the FDA’s conditional approval of KBroVet-CA1. Please see the full product label and package insert for details. Additionally, the tablets are no longer scored, nor contain cyanocobalamin (vitamin B-12). All other ingredients remain the same.
What does conditionally approved mean?
KBroVet-CA1 is conditionally approved by the FDA. This means that the product has been proven safe and has a reasonable expectation of effectiveness. The sponsor will continue to collect the evidence of effectiveness needed for the product to receive full approval. Conditionally approved animal drugs are limited to a specific use, which can be found on the package insert. Additional information on conditional approval can be found by searching http://fda.gov for “conditional approval.”
How does conditional approval differ from traditional/formal approval?
The FDA, following successful demonstration of efficacy, safety and manufacturing protocols, grants drug approvals. A conditional approval is granted for only certain types of treatments for serious or life-threatening conditions where demonstrating effectiveness requires complex or difficult studies. Once safety and manufacturing protocols have been proven, the FDA will consider an approval when there is a reasonable expectation of effectiveness for use. The conditional approval is for one year, must be renewed annually after showing progress toward full approval for up to four additional years.
As a veterinarian, can I transition a patient from the previous bottle of KBroVet tablets directly to the new KBroVet-CA1 tablets without a washout or transition period?
I’ve been using KBroVet for years and I thought it was already approved. Was it not? Is this a step backward for the product?
By way of a close partnership with the FDA due to a recognized marketplace need, PRN Pharmacal has manufactured KBroVet for nearly a decade as an unapproved drug, while working toward completion of a formal approval. At this juncture, the FDA granted conditional approval based on reasonable expectation of efficacy, demonstrated safety and approval of manufacturing controls. This is a step forward for the product in the eyes of the FDA.
What size is a KBroVet-CA1 tablet?
It is approximately the size of a dime.
Can you feed KBroVet-CA1 with peanut butter?
There have been no tests dosing dogs with Bromides and feeding peanut butter or any other food combinations, as there are too many variables. The key is to monitor the serum bromide levels to keep them in the 1-3 mg/mL range. The dosing and diet need to be balanced to achieve this range.
What is the flavoring?
Tablets are artificial chicken liver and drops are artificial butterscotch. There is no sucrose in the drops.
Should the oral solution be refrigerated after opening?
No. The product should be kept at room temperature.