Aratana Therapeutics, Inc. (NASDAQ: PETX), a pet therapeutics company focused on the licensing, development and commercialization of innovative biopharmaceutical products for companion animals, announced that it recently met with the U.S. Food and Drug Administration Center for Veterinary Medicine (CVM) regarding the proposed manufacturing transfer of ENTYCE® (capromorelin oral solution).
Aratana believes that it is in agreement with CVM on how to proceed. Aratana intends to resubmit the required prior approval submission in the coming weeks. If the submission is approved, Aratana believes it would be able to make ENTYCE commercially available by the fall of 2017.
"We are pleased to bring this innovative therapeutic forward as a new tool with which veterinarians can manage pets' medical needs," stated Steven St. Peter, M.D., President and Chief Executive Officer of Aratana Therapeutics. "Inappetence is an unmet medical need in millions of dogs with acute and chronic conditions, and ENTYCE is the first and only CVM-approved appetite stimulant."
IMPORTANT SAFETY INFORMATION
ENTYCE® (capromorelin oral solution) is for use in dogs only. Do not use in breeding, pregnant or lactating dogs. Use with caution in dogs with hepatic dysfunction or renal insufficiency. Adverse reactions in dogs may include diarrhea, vomiting, polydipsia, and hypersalivation. Should not be used in dogs that have a hypersensitivity to capromorelin. Please see the full Prescribing Information for more detail.
About Aratana Therapeutics
Aratana Therapeutics is a pet therapeutics company focused on licensing, developing and commercializing innovative therapeutics for dogs and cats. Aratana believes that it can leverage the investment in the human biopharmaceutical industry to bring therapeutics to dogs and cats in a capital and time efficient manner. Aratana's pipeline includes therapeutic candidates for the potential treatment of pain, inappetence, viral diseases, allergy, cancer and other serious medical conditions. Aratana believes the development and commercialization of these therapeutics will permit veterinarians and pet owners to manage pets' medical needs safely and effectively, resulting in longer and improved quality of life for pets. For more information, please visit www.aratana.com.