KBroVet-CA1 (potassium bromide) Chewable Tablets for Dogs, 250-mg, 60 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.

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.”

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.

Yes.

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.

It is approximately the size of a dime.

Yes, the tablets contain a proprietary flavoring to increase acceptance by dogs.