Aratana Files for FDA Approval of Label Expansion

Aratana Therapeutics, Inc., a company focused on innovative therapeutics for dogs and cats, announced earlier this month that it had filed for a label expansion with the US Food and Drug Administration's (FDA) Center for Veterinary Medicine for Nocita (bupivacaine liposome injectable suspension), a long-acting, local anesthetic that provides up to 72 hours of postoperative analgesia.

Currently, the product is approved for use in dogs to provide local postoperative analgesia for cranial cruciate ligament surgery. If the expansion is accepted, Nocita would be available for use in cats as a peripheral nerve block to provide regional postoperative analgesia following onychectomy.

"We believe veterinarians are in need of safe and effective, non-opioid alternatives to provide pain relief to their feline and canine patients," Ernst Heinen, DVM, PhD, chief development officer of Aratana Therapeutics, said.

The FDA’s review date is set for July 30.

Aratana made headlines earlier this year when its canine osteosarcoma vaccine, Live Listeria Vector (AT-014), was granted a conditional license by the US Department of Agriculture (USDA) Center for Veterinary Biologics. The vaccine uses a Listeria-based antigen delivery system that activates cytotoxic T cells.

As part of an extended field study, the vaccine was made available for purchase at approximately 24 veterinary oncology practice groups across the United States. If results of the new study are successful, the USDA may approve the vaccine and allow unrestricted sales throughout the United States.