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Aratana Therapeutics Granted FDA Approval of NOCITA® (bupivacaine liposome injectable suspension) 10 mL Vial
LEAWOOD, Kan., June 11, 2019 /PRNewswire/ -- 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. Please see the full Prescribing Information for more detail.
Forward-Looking Statements Disclaimer
This press release contains forward-looking statements (as that term is defined in the Private Securities Litigation Reform Act of 1995) and reflects Aratana's current beliefs. However, as with any pharmaceutical product, there are substantial risks and uncertainties in the process of development and commercialization. Among other things, all statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements and there can be no guarantee with respect to our ability to bring innovative therapeutics to the market; steps necessary for and timing of regulatory submissions and approvals of therapeutic candidates; study, development and commercialization of therapeutics or therapeutic candidates, including without limitation the potential use and timing of availability of the 10 mL vial size of NOCITA; ongoing efforts to commercialize ENTYCE and NOCITA; increased market recognition of and demand for our therapeutics; and statements regarding the Company's efforts, plans and opportunities, including, without limitation, advancing our therapeutic candidates and offering innovative therapeutics that help manage pet's medical needs safely and effectively and that result in longer and improved quality of life for pets. For further discussion of these and other risks and uncertainties, see Aratana's most recent Form 10-K and Form 10-Q filings with the United States Securities and Exchange Commission. These and other important factors discussed in Aratana's SEC filings could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent estimates or statements as of the date of this press release. While we may elect to update such forward-looking statements at some point in the future, we disclaim any obligation to do so, even if subsequent events cause our views to change, except as required under applicable law. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release.
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SOURCE Aratana Therapeutics