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About Fidelis Animal Health

We are a commercial stage company with an extensive pipeline utilizing our innovative drug delivery technology.
As experts in the acquisition, development, and marketing of unique pharmaceutical formulations that meet specialized veterinary needs, we are using our extensive experience to bring much-needed pharmaceuticals to market.
Our mission is to upgrade the standard of care for animals large and small with our innovative drug delivery technology.
We are focused on acquiring and developing products that will bring value-added specialty veterinary pharmaceuticals to the market across multiple treatment areas. This is fulfilling our vision to lead the industry with quality-driven pain management and other innovations using our proprietary extended-release technology. Our lead product – Ethiqa XR® (please read ISI and full box warning) – is now successfully commercialized and being used throughout the U.S.

Fidelis Animal Health is a privately held U.S.-based company serving the world from the Northeast pharmaceutical corridor:

  • Corporate headquarters located in New Jersey.
  • Lead product manufactured in Pennsylvania.
  • Supply chain sources and manufacturing sites and operations are in compliance with current Good Manufacturing Practices (cGMPs) regulated by the FDA.
  • Dedicated to providing pharmaceutical-grade products that are indexed by the FDA.

Important Safety Information

For Rats and Mice:
Only administer Ethiqa XR by subcutaneous injection. Ethiqa XR is not intended for intravenous, intra-arterial, intrathecal, intramuscular, or intra-peritoneal injection. Do not use on mice or rats with pre-existing respiratory deficiencies. Do not keep rats on wood chip-type bedding after administration of Ethiqa XR. Use caution with concomitant administration of Ethiqa XR with drugs that cause respiratory depression.

For Humans:
Ethiqa XR should only be administered by a veterinarian or laboratory staff trained in the handling of potent opioids. Protective clothing is recommended to avoid direct contact with human skin or mucus membranes which could result in absorption of buprenorphine and adverse reactions. Not for use in humans.

For more information, consult the Prescribing Information including the Boxed Warning.

WARNING: ABUSE POTENTIAL and LIFE-THREATENING RESPIRATORY DEPRESSION and ACCIDENTAL EXPOSURE

Abuse Potential

Ethiqa XR contains buprenorphine, a high-concentration (1.3 mg/mL) opioid agonist and Schedule III controlled substance with an abuse potential similar to other Schedule III opioids. The high concentration may be a particular target for human abuse. Buprenorphine has opioid properties that in humans may lead to dependence of the morphine type. Abuse of buprenorphine may lead to low or moderate physical dependence or high psychological dependence. The risk of abuse by humans should be considered when storing, administering, and disposing of Ethiqa XR. Persons at increased risk for opioid abuse include those with a personal or family history of substance abuse (including drug or alcohol abuse or addiction) or mental illness (suicidal depression). Because of human safety risks, this drug should be used only with veterinary supervision.

Do not dispense Ethiqa XR.

Life-Threatening Respiratory Depression

The concentration of buprenorphine in Ethiqa XR is 1.3 mg/mL. Respiratory depression, including fatal cases, may occur with abuse of Ethiqa XR. Ethiqa XR has additive CNS depressant effects when used with alcohol, other opioids, or illicit drugs that cause central nervous system depression. Because of the potential for adverse reactions associated with accidental injection, Ethiqa XR should only be administered by a veterinarian or laboratory staff trained in the handling of potent opioids.