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Aratana seeks fourth FDA approval with Nocita label extension


Jun 01, 2018 - Animal Pharm
By Joseph Harvey
Animal Pharm
June 1, 2018


Aratana Therapeutics is one step closer to its fourth US FDA approval after it submitted a supplemental New Animal Drug Application (NADA) for Nocita.

Nocita (bupivacaine liposome injectable suspension) is currently approved as a local post-operative analgesic for cranial cruciate ligament surgery in dogs. The NADA aims at allowing the product to be used in cats to provide regional post-operative analgesia following onychectomy.

The long-acting, local anesthetic provides up to 72 hours of analgesia post-operatively using multi-vesicular liposomal technology. Nocita first gained US approval in 2016, when it became Aratana's third FDA authorization in five months. The product went to market in late 2016 and made 2017 revenues of $2.8 million.

The FDA's Animal Drug User Fee Act review date for the NADA is set for July 30, 2018.

Dr Ernst Heinen, chief development officer at Leawood, Kansas-based Aratana, said: "We believe veterinarians are in need of safe and effective, non-opioid alternatives to provide pain relief to their feline and canine patients. If the supplemental NADA is approved, Nocita will help control feline pain for up to 72 hours by blocking pain signals at their source, the nerve."

Earlier this year, the company updated Animal Pharm on its growing sales base. In 2018, Aratana will continue to work on registering products in Europe and aims to complete study enrolment for its feline weight management candidate (AT-002 capromorelin).

Reprinted with permission of Animal Pharm News

 

 

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