Fidelis Animal Health, Inc. Announces Major Label Expansion For Ethiqa XR®

Ethiqa
XR,
an
extended-release
buprenorphine,
adds captive rodents and laboratory rabbits to label for 72-hour control of
post-procedural
pain.

NORTH BRUNSWICK, N.J., Nov. 5, 2024 /PRNewswire/ -- Fidelis Animal Health, Inc. has received notification from the Food and Drug Administration (FDA) that Ethiqa XR (buprenorphine extended-release injectable suspension) 1.3 mg/mL is now indicated for the control of post-procedural pain in captive rodents and laboratory rabbits.
With Ethiqa XR, veterinarians have an FDA-indexed, Pharmaceutical grade, cGMP extended-release buprenorphine for use in mice, naked mole rats, gerbils, hamsters, rats, chinchillas, guinea pigs, prairie dogs, ferrets, laboratory rabbits, and non-human primates.

"We are excited to bring these new indications to veterinarians in general and specialty practices, and in the research community. Ethiqa XR meets their high expectations for efficacy, safety, and quality, and makes it so much easier to comply with FDA GFI #256, which stresses the importance of using legal, FDA-indexed animal medications instead of compounded drugs for office stock and individual patient use1," said Michael Wells, Board Chair and CEO.

"Ethiqa XR is an innovative form
of buprenorphine that uses Fidelis Animal
Health's Fidelipid LAITM technology,
a
patented lipid-based
formulation
that
safely delivers
72
hours
of
clinical analgesia
with
just one subcutaneous injection2," says Dr. Steven Leary, the company's Chief Medical Officer. "It is manufactured in compliance with cGMP standards, meeting strict specifications to ensure consistency in quality and potency. Ethiqa XR is sterilized, with no harmful excipients, endotoxins, or microbial contamination."

Since
its
launch
to laboratory veterinarians in
2020,
Ethiqa
XR is
currently
being
used
in
over
five hundred
institutions
across
the
country, including those at the top ten pharmaceutical companies, many of the country's elite academic institutions, hospital systems, and several government research facilities. Use is rapidly growing among practicing veterinarians who treat small mammals.

Ethiqa XR is easily and readily available from the major national veterinary distributors, including Covetrus, Patterson, MWI Animal Health and Midwest Veterinary Supply. For more information, visit .

IMPORTANT
SAFETY INFORMATION

For
Captive Rodents,
Ferrets, Laboratory Rabbits and Non-Human Primates:

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
in
animals with
pre-existing
respiratory
compromise.

Death has been reported when non-steroidal anti-inflammatory drugs (NSAIDs such as meloxicam and carprofen) and Ethiqa XR have been administered concomitantly in mice.

Do not house rats on wood chip-type bedding after administration of Ethiqa XR. Pica involving wood chip type bedding can be lethal.

Ethiqa XR may cause sedation, decreased blood pressure, decreased heart rate,
decreased gastrointestinal mobility, and respiratory depression.
Use caution with
concomitant
administration
of
Ethiqa
XR
with
drugs
that
cause
respiratory depression. Animals should be monitored for signs of decreased cardiovascular and
respiratory function when receiving Ethiqa XR.

The safety of Ethiqa XR has not been evaluated
in pregnant, lactating, neonatal, or
immune-compromised animals.

For
Humans:

Not
for
use
in
humans.
Keep
out
of
reach
of
children
and pets.

Ethiqa
XR
contains
buprenorphine,
a
Schedule
III
controlled
substance
with
an
abuse
potential
similar to other Schedule III opioids, which may lead to overdose and death.

Ethiqa
XR
should
be
handled
appropriately
to
minimize
the
risk
of
misuse,
abuse,
addiction,
and
criminal diversion, including restriction of access, the use of accounting procedures, and proper disposal methods as appropriate to the laboratory setting and as required by law.

Ethiqa XR should only be handled and administered by a veterinarian, veterinarian technician, or laboratory
staff
trained
in
the
handling of
potent
opioids. Wear protective
clothing
when
administering Ethiqa XR to avoid direct contact with human skin, eyes, oral, or other mucus membranes which could result in absorption of buprenorphine and adverse reactions.

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

About Fidelis Animal Health: Fidelis Animal Health is a commercial stage company offering exceptional expertise in the acquisition, development, and marketing of unique pharmaceutical formulations. The company is committed to leading the industry with developing and bringing to the market quality-driven therapeutics and additional innovations for all animals, small and large, using our proprietary extended- release technology.

For
more
information
about Fidelis
Animal
Health, please
visit
.

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