Aratana Therapeutics requests FDA approval for NOCITA®

Aratana Therapeutics, Inc., a pet therapeutics company that is dedicated to developing, licensing, and selling innovative biopharmaceutical products specifically for companion animals, recently sent an administration New Animal Drug Application (NADA) to the U.S. Food and Drug Administration (FDA) for its new NOCITA.

NOCITA (bupivacaine liposome injectable suspension) needs approval from the FDA’s Center for Veterinary Medicine (CVM). NOCITA is a local post-operative analgesia for dogs undergoing cranial cruciate ligament surgery. The deadline for approval from the Animal Drug User Fee Act (ADUFA) is Aug. 28.

The company expects that the new injection will be distributed and commercially selling to veterinarians this fall.

NOCITA is effective for up to 72 hours after the surgery. The injection releases bupivacaine gradually, using multi-vesicular liposomes that are put into the tissue. This is a huge benefit to veterinarians, who currently have to use several different injections and treatments for dogs’ cranial cruciate ligament surgery.

"Today veterinarians manage post-operative pain in a multi-modal way with local anesthetics, opioids, NSAIDs and other products," Ernst Heinen, Chief Development Officer of Aratana Therapeutics, said. "If approved, Nocita would be a safe and effective, non-opioid alternative to provide sustained pain control for up to 72 hours post-surgery."