ARATANA THERAPEUTICS: Granted FDA Approval of NOCITA® (bupivacaine liposome injectable suspension) 10 mL Vial


Aratana Therapeutics issued the following announcement on June 11.

Aratana Therapeutics, Inc. (Nasdaq: PETX), a pet therapeutics company focused on the development and commercialization of innovative therapeutics for dogs and cats, today announced the U.S. Food and Drug Administration's Center for Veterinary Medicine (CVM) approved an additional vial size (10 mL) for NOCITA® (bupivacaine liposome injectable suspension). NOCITA is currently available in a 20 mL vial size and Aratana continues to anticipate commercial availability of the NOCITA 10 mL vial by fall 2019.

"Since its launch in 2016, Nocita has drastically changed veterinary multimodal pain management protocols because it safely and effectively controls pain in patients for up to 72 hours following certain canine and feline surgeries," states Dr. Ernst Heinen, Chief Development Officer for Aratana Therapeutics. "Ultimately, we believe a smaller vial size may allow for expanded use and improve the level of care veterinarians provide for certain painful surgeries."

NOCITA is FDA-approved for single-dose infiltration into the surgical site to provide local post-operative analgesia for cranial cruciate ligament surgery in dogs and as a peripheral nerve block to provide regional post-operative analgesia following owner-elected onychectomy in cats. For those interested in learning more about NOCITA, please visit nocita.aratana.com.

About Aratana Therapeutics

Aratana Therapeutics is a pet therapeutics company focused on developing and commercializing innovative therapeutics for dogs and cats. Our mission is to successfully develop and deliver best-in-class therapeutics, provide comprehensive service to veterinarians and serve as a collaborator of choice for human and animal health companies. We believe our therapeutics are highly differentiated, resolve recognizable needs in compelling markets and have therapeutic profiles superior to the standard of care. For more information, please visit www.aratana.com.

IMPORTANT SAFETY INFORMATION

NOCITA® (bupivacaine liposome injectable suspension) is for local infiltration injection in dogs only. Do not use in dogs younger than 5 months of age, that are pregnant, lactating or intended for breeding. Do not administer by intravenous or intra‐arterial injection. Adverse reactions in dogs may include discharge from incision, incisional inflammation and vomiting. Avoid concurrent use with bupivacaine HCl, lidocaine or other amide local anesthetics. Please see the full Prescribing Information for more detail.

NOCITA® (bupivacaine liposome injectable suspension) is for use as a peripheral nerve block in cats only. Do not use in cats younger than 5 months of age, that are pregnant, lactating, or intended for breeding. Do not administer by intravenous or intra‐arterial injection. Adverse reactions in cats may include elevated body temperature, infection or chewing/licking at the surgical site. Avoid concurrent use with bupivacaine HCl, lidocaine or other amide local anesthetics. 

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