Label: CREDELIO- lotilaner tablet, chewable

Chewable Tablets

For oral use in dogs

Caution:

Federal law restricts this drug to use by or on the order of a licensed veterinarian.

CREDELIO (lotilaner) is a beef-flavored, chewable tablet for oral administration to dogs and puppies according to their weight. Each chewable tablet is formulated to provide a minimum lotilaner dosage of 9 mg/lb (20 mg/kg).

Lotilaner has the chemical composition of 5-[(5S)-4,5-dihydro-5-(3,4,5-trichlorophenyl)-5-(trifluoromethyl)-3-isoxazolyl]-3-methyl-N-[2-oxo-2-[(2,2,2-trifluoroethyl)amino]ethyl]-2-thiophenecarboxamide.

CREDELIO kills adult fleas and is indicated for the treatment and prevention of flea infestations (Ctenocephalides felis) and the treatment and control of tick infestations [Amblyomma americanum (lone star tick), Dermacentor variabilis (American dog tick), Ixodes scapularis (black-legged tick), Rhipicephalus sanguineus (brown dog tick), and Haemaphysalis longicornis (longhorned tick)] for one month in dogs and puppies 8 weeks of age and older, and weighing 4.4 pounds or greater. CREDELIO is indicated for the prevention of Borrelia burgdorferi infections as a direct result of killing Ixodes scapularis vector ticks.

CREDELIO is given orally once a month, at the minimum dosage of 9 mg/lb (20 mg/kg).

Dosage Schedule:

CREDELIO must be administered with food (see Clinical Pharmacology).

Treatment with CREDELIO can begin at any time of the year and can continue year-round without interruption.

There are no known contraindications for the use of CREDELIO.

Not for human use. Keep this and all drugs out of the reach of children. Keep CREDELIO in a secure location out of reach of dogs, cats, and other animals to prevent accidental ingestion or overdose.

Lotilaner is a member of the isoxazoline class. This class has been associated with neurologic adverse reactions including tremors, ataxia, and seizures. Seizures have been reported in dogs receiving isoxazoline class drugs, even in dogs without a history of seizures. Use with caution in dogs with a history of seizures or neurologic disorders.

The safe use of CREDELIO in breeding, pregnant or lactating dogs has not been evaluated.

In a well-controlled U.S. field study, which included 284 dogs (198 dogs treated with CREDELIO and 86 dogs treated with an oral active control), there were no serious adverse reactions.

Over the 90-day study period, all observations of potential adverse reactions were recorded. Reactions that occurred at an incidence of 1% or greater are presented in the following table.

Dogs with Adverse Reactions in the Field Study

In addition, one dog experienced intermittent head tremors within 1.5 hours of administration of vaccines, an ear cleaning performed by the owner, and its first dose of CREDELIO. The head tremors resolved within 24 hours without treatment. The owner elected to withdraw the dog from the study.

In an Australian field study, one dog with a history of seizures experienced seizure activity (tremors and glazed eyes) six days after receiving CREDELIO. The dog recovered without treatment and completed the study. In the U.S. field study, two dogs with a history of seizures received CREDELIO and experienced no seizures throughout the study.

In three well-controlled European field studies and one U.S. laboratory study, seven dogs experienced episodes of vomiting and four dogs experienced episodes of diarrhea between 6 hours and 3 days after receiving CREDELIO.

The following adverse events are based on post-approval adverse drug experience reporting for CREDELIO. Not all adverse events are reported to FDA/CVM. It is not always possible to reliably estimate the adverse event frequency or establish a causal relationship to product exposure using these data.

The following adverse events reported in dogs are listed in decreasing order of reporting frequency:

Vomiting, diarrhea (with and without blood), lethargy, anorexia, seizure, pruritus, ataxia, urinary-related signs (polyuria, polydipsia, urinary incontinence, and inappropriate urination), and muscle tremor.

To report suspected adverse events, for technical assistance or to obtain a copy of the Safety Data Sheet (SDS), contact Elanco US Inc. at 1-888-545-5973.

For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS or http:/www.fda.gov/reportanimalae.

Following oral administration of 43 mg/kg (approximately 1X the maximum labeled dose), peak lotilaner concentrations were achieved between 6 hours and 3 days in dogs 2 months of age and between 1 and 7 days in dogs 10 months of age. Dogs 2 months of age had a shorter elimination half-life (average of 9.6 days) than at 10 months of age (average of 28.4 days). Due to reduced drug bioavailability in the fasted state, CREDELIO must be administered with a meal or within 30 minutes after feeding.

Lotilaner is an ectoparasiticide belonging to the isoxazoline group. Lotilaner inhibits insect and acarine gamma-aminobutyric acid (GABA)-gated chloride channels. This inhibition blocks the transfer of chloride ions across cell membranes, which results in uncontrolled neuromuscular activity leading to death of insects and acarines. The selective toxicity of lotilaner between insects and acarines and mammals may be inferred by the differential sensitivity of the insects and acarines' GABA receptors versus mammalian GABA receptors.

In well-controlled European laboratory studies, CREDELIO began to kill fleas four hours after administration or infestation, with greater than 99% of fleas killed within eight hours after administration or infestation for 35 days. In a well-controlled U.S. laboratory study, CREDELIO demonstrated 100% effectiveness against adult fleas 12 hours after administration or infestation for 35 days.

In a 90-day well-controlled U.S. field study conducted in households with existing flea infestations of varying severity, the effectiveness of CREDELIO against fleas on Days 30, 60 and 90 compared to baseline was 99.5%,100% and 100%, respectively. Dogs with signs of flea allergy dermatitis showed improvement in erythema, papules, scaling, alopecia, dermatitis/pyodermatitis and pruritus as a direct result of eliminating fleas.

In a well-controlled laboratory study, CREDELIO killed fleas before they could lay eggs, thus preventing subsequent flea infestations for 30 days after the start of treatment of existing flea infestations.

In well-controlled laboratory studies, CREDELIO demonstrated > 97% effectiveness against Amblyomma americanum, Dermacentor variabilis, Ixodes scapularis, Rhipicephalus sanguineus, and Haemaphysalis longicornis ticks 48 hours after administration or infestation for 30 days. In a well-controlled European laboratory study, CREDELIO started killing Ixodes ricinus ticks within four hours after administration.

In two separate, well-controlled laboratory studies, CREDELIO was effective at preventing Borrelia burgdorferi infections after dogs were infested with Ixodes scapularis vector ticks.

Store at 15-25°C (59 -77°F), excursions permitted between 5 to 40°C (41 to 104°F).

CREDELIO is available in five chewable tablet sizes for use in dogs: 56.25, 112.5, 225, 450, and 900 mg lotilaner.

Each chewable tablet size is available in color-coded packages of 1, 3 or 6 chewable tablets.

Approved by FDA under NADA # 141-494

Manufactured for:
Elanco US Inc
Indianapolis, IN 46221 USA
Credelio.com
Revised February 2026

Credelio, Elanco and the diagonal bar logo are trademarks of Elanco or its affiliates.

© 2026 Elanco or its affiliates

ElancoTM

Credelio™
(lotilaner)
Chewable Tablets
For oral use in dogs

Original EUA Authorized Date: 10/24/2025

Emergency Use Authorization of Credelio (lotilaner) Chewable Tablets for NWS

The U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for the emergency use of the approved product Credelio (lotilaner) chewable tablets for the treatment of infestations caused by NWS (Cochliomyia hominivorax) larvae (myiasis) in dogs and puppies. Credelio is not approved for this use.

Credelio (lotilaner) (NADA 141-494) is approved for other uses in dogs and puppies.1

Limitations of Authorized Use

Credelio (lotilaner) chewable tablets is authorized for this use only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of Credelio (lotilaner) chewable tablets under section 564(b)(1) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated or the authorization is revoked sooner.

Justification for Emergency Use of Animal Drugs for NWS

The Secretary of the U.S. Department of Health and Human Services (HHS) has:

•

determined that there is a significant potential for a public health emergency that has a significant potential to affect national security or the health and security of United States citizens living abroad and that involves NWS (Cochliomyia hominivorax); and

•

declared that circumstances exist justifying the authorization of emergency use of animal drugs to treat or prevent NWS myiasis in animals.2

An EUA is an FDA authorization for the emergency use of an unapproved product or unapproved use of an approved product (i.e., drug, biological product, or device) in the United States under certain circumstances declared by the Secretary of HHS to justify emergency use authorization, including, among others, a determination that there is a public health emergency or a significant potential for a public health emergency that may affect national security and that involves a biological agent.3

Criteria for issuing this EUA include:

•

The biological agent(s) can cause a serious or life-threatening disease or condition;

•

Based on the totality of available scientific evidence (including data from adequate and well-controlled clinical trials, if available), it is reasonable to believe that:

o

the product may be effective in diagnosing, preventing, or treating the serious or life-threatening disease or condition; and

o

the known and potential benefits of the product - when used to diagnose, prevent, or treat such disease or condition - outweigh the known and potential risks of the product; and

•

There is no adequate, approved,4 and available alternative to the product for diagnosing, preventing, or treating the serious or life-threatening disease or condition.5

Caution: Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Product Description

Refer to the Credelio package insert for full Product Description information.

Dosage and Administration

Credelio is given orally at the minimum dosage of 9 mg/lb (20 mg/kg).

Dosage Schedule:

Credelio must be administered with food.

Credelio is not available as scored tablets. The effectiveness of the administration of less than full tablets has not been evaluated.

Risk-Benefit Consideration for Dogs on Other Isoxazolines:

If a dog is currently receiving another isoxazoline product for routine ectoparasite control, veterinarians should consider administering Credelio to dogs diagnosed with NWS myiasis based on a risk-benefit assessment and the emergency nature of NWS myiasis treatment.

Information Supporting Emergency Use Authorization

Based on the totality of scientific evidence available to FDA, including data from published scientific literature, it is reasonable to believe that Credelio (lotilaner) chewable tablets may be effective for the treatment of infestations caused by NWS (Cochliomyia hominivorax) larvae (myiasis) in dogs and puppies; and when used under the conditions described in the authorization, the known and potential benefits of Credelio (lotilaner) chewable tablets outweigh the known and potential risks.

A study conducted by do Vale et al.6 evaluated the effectiveness of Credelio for the treatment of naturally acquired NWS myiasis in dogs in Brazil. Eleven client-owned dogs with active myiasis caused by C. hominivorax larvae were enrolled based on lesion severity and larval burden. The age of the enrolled dogs (5 males, 6 females) ranged from 1.5 to 10.0 years, weighing between 3.3 to 25.0 kg. All dogs received a single oral administration of Credelio at doses ranging from 23.9 to 40.9 mg/kg body weight, following the dose bands for the approved flea and tick indications. The study did not include a control group.

After treatment, the dogs were kept in individual kennels with a removable tray. The dogs were observed 2- and 6-hours post-treatment, at which times expelled larvae were collected and quantified. At 24 hours post-treatment, the remaining larvae were mechanically removed from the wound and counted.

The study demonstrated 100% overall effectiveness (number of expelled live and dead larvae and dead larvae mechanically removed) against C. hominivorax larvae at 24 hours post-treatment with expulsion of larvae of 80.5% and 93% at 2 and 6 hours after treatment, respectively. The mean larvicidal effectiveness was 41.1% at 24 hours. There were no adverse reactions during the study.

There are limitations of the data supporting the benefits of Credelio for the treatment of infestations caused by NWS larvae. The do Vale et al. study was conducted in a limited population of 11 naturally infested dogs in Brazil, and the inferential value to the United States population is unknown. The primary mechanism of action against C. hominivorax appears to be live larval expulsion. Additionally, the use of mechanical removal coupled with the lack of a control group confound the ability to define a pure treatment effect.

The available clinical data supporting the effectiveness of Credelio against C. hominivorax larvae, along with the established safety profile, support the potential benefit of Credelio in the authorized patient population for the treatment of infestations caused by NWS larvae.

Contraindications

There are no known contraindications for the use of Credelio.

Warnings

User Safety Warnings

Not for human use. Keep this and all drugs out of the reach of children. Keep Credelio in a secure location out of reach of dogs, cats, and other animals to prevent accidental ingestion or overdose.

To obtain a Safety Data Sheet (SDS), contact Elanco US Inc. at 1-888-545-5973 or https://www.elanco.com/us/elanco-safety-data-sheets.

Precautions

Lotilaner is a member of the isoxazoline class. This class has been associated with neurologic adverse reactions including tremors, ataxia, and seizures. Seizures have been reported in dogs receiving isoxazoline class drugs, even in dogs without a history of seizures. Use with caution in dogs with a history of seizures or neurologic disorders. The safe use of Credelio in breeding, pregnant, or lactating dogs has not been evaluated. The safety of Credelio has not been evaluated in dogs less than 8 weeks of age or less than 4.4 lbs.

Adverse Reactions

Refer to the Credelio package insert for full prescribing information, including Animal Safety, Adverse Reactions, and Post-Approval Experience.

As described in the Letter of Authorization, veterinary facilities and veterinarians must report all SERIOUS ADVERSE EVENTS* potentially related to Credelio (lotilaner) use under this EUA (1) by contacting Elanco US Inc. at 1-888-545-5973, (2) by downloading and submitting Form FDA 1932a available at https://www.fda.gov/reportanimalae, or (3) contacting FDA at 1-888-FDA-VETS to request this form.

When reporting adverse events on Form FDA 1932a, include the following elements when applicable and/or available:

•

Patient demographics (e.g., age, species and breed, sex, weight)

•

The statement “Credelio (lotilaner) use for NWS under an EUA” under the “Adverse Event/Product Problem/Product Use Error” heading

•

Information about the serious adverse event (e.g., signs and symptoms, test/laboratory data, timing of drug administration in relation to the occurrence of the event, duration of the event, treatment required to mitigate the event, evidence of event improvement/disappearance after stopping/reducing the dosage, evidence of reappearance after reintroduction, clinical outcomes)

•

Patient’s pre-existing medical conditions and use of concomitant products

•

Information about the product (e.g., dosage, route of administration, lot number)

*Serious adverse events are defined as:

•

Death

•

A life-threatening adverse event

•

An event that causes an abortion, stillbirth, or infertility

•

A congenital anomaly or birth defect in o spring of treated animals

•

A prolonged or permanent disability (e.g., persistent or significant incapacity or disruption of normal life functions)

•

An event that requires professional intervention (e.g., important medical events that may require a medical/surgical intervention to prevent a death, life-threatening event, hospitalization, disability)

Reporting of lack of effectiveness, nonserious adverse events, or product quality defects is strongly encouraged via the mechanisms and including the information identified above for SERIOUS ADVERSE EVENTS.

Additional Information for Veterinarians

Veterinary facilities and veterinarians will ensure that they are aware of and adhere to the terms of the Letter of Authorization. Fact Sheets will be made available to veterinarians.

Veterinary facilities and veterinarians will ensure that the client is aware that the drug is authorized for emergency use, but not approved, for the treatment of NWS myiasis and advise the client of the risks, benefits, and any alternatives.

Veterinary facilities will maintain health records that include the following information: client name, patient name, patient age, disease manifestation, number of doses prescribed or administered per patient, lot number prescribed or administered, and other drugs co-administered. The records shall be maintained in a manner that allows veterinary facilities to identify in a reasonable time which patients received drugs subject to this EUA.

Veterinary facilities will maintain any health records for the authorized use in the Letter of Authorization for at least two years following the termination of the declaration or the revocation of the authorization, or until notified by HHS, or FDA, whichever is sooner. Such records will be made available to Elanco US Inc., HHS, and FDA for inspection upon request.

Information for Client (e.g., Animal Owner or Caretaker)

The lifecycle for C. hominivorax is as short as 21 days and wounds can be rapidly infested. Proper wound care and management practices are essential for preventing NWS myiasis. Dogs may become reinfested following treatment.

Animal owners should be advised that:

•

Gloves should be worn if cleaning the wound, or the dog’s bedding, or disposing of larvae.

•

Dogs should be housed to prevent exposure to NWS flies until wounds have fully healed.

•

Live larvae may exit the wound and be deposited on bedding or areas where the dog sits or lies after treatment.

•

If expelled larvae are seen, owners should place the larvae in a sealed container with rubbing alcohol.

•

If there is worsening of the wound, the owner should contact the veterinarian.

How Supplied

Credelio is available in five chewable tablet sizes for use in dogs: 56.25, 112.5, 225, 450, and 900 mg lotilaner. Each chewable tablet size is available in color-coded packages of 1, 3, or 6 chewable tablets.

Storage Information

Store at 15-25°C (59-77°F), excursions permitted between 5 to 40°C (41 to 104°F).

Manufactured for:

Elanco US Inc

Greenfield, IN 46140 USA

Revised 03/27/2026

Credelio, Elanco and the diagonal bar logo are trademarks of Elanco or its affiliates.

© 2025 Elanco or its affiliates

PA104447X

W2a

ElancoTM

1

On January 19, 2018, Credelio was approved to kill adult fleas and is indicated for the treatment of flea infestations (Ctenocephalides felis) and the treatment and control of tick infestations [Amblyomma americanum (lone star tick), Dermacentor variabilis (American dog tick), Ixodes scapularis (black-legged tick) and Rhipicephalus sanguineus (brown dog tick)] for one month in dogs and puppies 8 weeks of age and older, and weighing 4.4 pounds or greater. On September 3, 2019, Credelio received a supplemental approval for the prevention of flea infestations (Ctenocephalides felis) for one month in dogs and puppies 8 weeks of age and older, and weighing 4.4 pounds or greater. On October 24, 2025, Credelio received a supplemental approval for the treatment and control of Haemaphysalis longicornis (longhorned tick) tick infestations for one month in dogs and puppies 8 weeks of age and older, weighing 4.4 pounds or greater, and for the prevention of Borrelia burgdorferi infections as a direct result of killing Ixodes scapularis vector ticks.

2

See U.S. Department of Health and Human Services, Declaration of Emergency Pursuant to the Federal Food, Drug, and Cosmetic Act for New World Screwworm, August 20, 2025: https://www.federalregister.gov/documents/2025/08/20/2025-15918/declaration-of-emergency-pursuant-to-the-federal-food-drug-and-cosmetic-act-for-new-world-screwworm

3

Emergency Use Authorization of Medical Products and Related Authorities | FDA (https://www.fda.gov/regulatory-information/search-fda-guidance-documents/emergency-use-authorization-medical-products-and-related-authorities)

4

“Approved” products include conditionally approved products for purposes of EUAs issued under section 564 of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 360bbb-3.

5

https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization

6

do Vale TL, Costa AR, Miranda LM, Silva GF, Silva NCS, Lima TB, Chaves DP, Sager H, Lasmar PVF, Costa-Junior LM. Efficacy of lotilaner against myiasis caused by Cochliomyia hominivorax (Diptera: Calliphoridae) in naturally infested dogs. Parasit Vectors. 2023;16(1):86.

3 Tablets

Dogs &
puppies

4.4-6.0 lbs

Credelio™
(lotilaner)

For the treatment and
prevention of flea infestations
and for the treatment and control
of tick infestations in dogs and
puppies 8 weeks of age and older

56.25 mg chewable tablet

Kills fleas

Kills ticks

Monthly dose

Give with
food

CAUTION: Federal law restricts this drug to use by
or on the order of a licensed veterinarian.

Approved by FDA under NADA # 141-494

ElancoTM

3 Tablets

Dogs &
puppies

6.1-12.0 lbs

Credelio™
(lotilaner)

For the treatment and
prevention of flea infestations
and for the treatment and control
of tick infestations in dogs and
puppies 8 weeks of age and older

112.5 mg chewable tablet

Kills fleas

Kills ticks

Monthly dose

Give with
food

CAUTION: Federal law restricts this drug to use by
or on the order of a licensed veterinarian.

Approved by FDA under NADA # 141-494

ElancoTM

3 Tablets

Dogs &
puppies

12.1-25.0 lbs

Credelio™
(lotilaner)

For the treatment and
prevention of flea infestations
and for the treatment and control
of tick infestations in dogs and
puppies 8 weeks of age and older

225 mg chewable tablet

Kills fleas

Kills ticks

Monthly dose

Give with
food

CAUTION: Federal law restricts this drug to use by
or on the order of a licensed veterinarian.

Approved by FDA under NADA # 141-494

ElancoTM

3 Tablets

Dogs &
puppies

25.1-50.0 lbs

Credelio™
(lotilaner)

For the treatment and
prevention of flea infestations
and for the treatment and control
of tick infestations in dogs and
puppies 8 weeks of age and older

450 mg chewable tablet

Kills fleas

Kills ticks

Monthly dose

Give with
food

CAUTION: Federal law restricts this drug to use by
or on the order of a licensed veterinarian.

Approved by FDA under NADA # 141-494

ElancoTM

3 Tablets

Dogs &
puppies

50.1-100.0 lbs

Credelio™
(lotilaner)

For the treatment and
prevention of flea infestations
and for the treatment and control
of tick infestations in dogs and
puppies 8 weeks of age and older

900 mg chewable tablet

Kills fleas

Kills ticks

Monthly dose

Give with
food

CAUTION: Federal law restricts this drug to use by
or on the order of a licensed veterinarian.

Approved by FDA under NADA # 141-494

ElancoTM

For New World
screwworm (NWS)
under Emergency
Use Authorization
(EUA)

Fact Sheet

www.credelio-nws.com

EP104447A