This section highlights FDA-related milestones and regulatory updates for drugs developed by Elanco Animal Health (ELAN).
Over the past two years, Elanco Animal Health has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
Befrena, Credelio, Credelio®, Zenrelia, TruCan™, and Bovaer. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Select a button below to view the list of FDA events for that drug.
Befrena FDA Regulatory Events
Befrena is a drug developed by Elanco Animal Health for the following indication: targeting canine allergic and atopic dermatitis.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Befrena
- Announced Date:
- December 31, 2025
- Indication:
- targeting canine allergic and atopic dermatitis.
Announcement
Elanco Animal Health announced its latest entry into the rapidly growing canine dermatology space with the U.S. Department of Agriculture (USDA) approval of Befrena™ (tirnovetmab), a new anti-IL31 monoclonal antibody (mAb) injection targeting canine allergic and atopic dermatitis.
AI Summary
Elanco announced U.S. Department of Agriculture approval of Befrena™ (tirnovetmab), an anti‑IL‑31 monoclonal antibody injection for canine allergic and atopic dermatitis. Befrena is shown effective for dogs of any age and is recommended at a 6–8 week dosing interval after treatment, offering longer between‑dose coverage than a current competitor with a 4–8 week schedule. Elanco expects to launch Befrena in the first half of 2026.
The approval positions Elanco deeper in the fast‑growing canine dermatology market and strengthens its work with monoclonal antibodies. Canine allergic and atopic dermatitis is common in practice — studies cited by Elanco indicate nearly all veterinarians routinely treat atopic dermatitis and that itchy dogs make up a large share of caseloads. Elanco says Befrena gives veterinarians and pet owners another long‑lasting option to manage itch and improve dogs’ quality of life. More information will be available through Elanco’s Befrena resources for veterinarians.
Read Announcement
Credelio Quattro FDA Regulatory Timeline and Events
Credelio Quattro is a drug developed by Elanco Animal Health for the following indication: treatment of infestations caused by New World screwworm larvae (myiasis) in dogs.
This drug is approved by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Credelio Quattro
- Announced Date:
- December 18, 2025
- Indication:
- treatment of infestations caused by New World screwworm larvae (myiasis) in dogs.
Announcement
Elanco Animal Health Incorporated announced it has received conditional approval from the U.S. Food and Drug Administration (FDA) for Credelio Quattro™-CA1 (lotilaner, moxidectin, praziquantel, and pyrantel chewable tablets) for the treatment of infestations caused by New World screwworm larvae (myiasis) in dogs.
AI Summary
Elanco announced the U.S. Food and Drug Administration has granted conditional approval for Credelio Quattro‑CA1, a chewable tablet containing lotilaner, moxidectin, praziquantel, and pyrantel, for treating infestations caused by New World screwworm larvae (myiasis) in dogs and puppies 8 weeks of age and older and weighing at least 3.3 pounds. The approval allows use of this companion animal product against screwworm while Elanco completes full effectiveness data.
The conditional approval was supported by a peer‑reviewed study in Parasites & Vectors showing oral lotilaner at the minimum recommended dose achieved 100% efficacy against Cochliomyia hominivorax larvae within 24 hours in naturally infested dogs. New product labeling reflecting the conditions of use is expected in 2026. With this approval, Credelio Quattro‑CA1 adds screwworm treatment to its parasite protection profile, giving veterinarians and pet owners an additional option if the fly is detected in the U.S.
Read Announcement- Drug:
- Credelio Quattro
- Announced Date:
- October 27, 2025
- Indication:
- lotilaner, moxidectin, praziquantel, and pyrantel chewable tablets monthly chewable tablet for dogs eight weeks of age or older.
Announcement
Elanco Animal Health announced label expansions for two of its leading canine prescription parasiticides, Credelio Quattro (lotilaner, moxidectin, praziquantel, and pyrantel chewable tablets) and Credelio (lotilaner), with both product labels updated
AI Summary
On October 27, 2025, Elanco Animal Health announced label expansions for Credelio Quattro and Credelio, two leading canine prescription parasiticides. Both labels now include a claim for prevention of Lyme disease as a direct result of killing black-legged ticks (Ixodes scapularis).
They also now cover treatment and control of invasive longhorned tick (Haemaphysalis longicornis) infestations. This rapidly spreading tick species is found in 22 states and poses a growing threat to dogs and humans alike.
Driven by the active ingredient lotilaner, these chewable tablets deliver fast and sustained tick kill. With more than 422,000 Lyme cases in dogs reported this year, the updates offer timely, comprehensive protection.
Elanco’s expanded labels underscore the company’s commitment to innovation, helping veterinarians and pet owners safeguard dogs against emerging parasitic threats year-round.
Read Announcement- Drug:
- Credelio Quattro
- Announced Date:
- October 7, 2024
- Indication:
- lotilaner, moxidectin, praziquantel, and pyrantel chewable tablets monthly chewable tablet for dogs eight weeks of age or older.
Announcement
Elanco Animal Health announced the U.S. Food and Drug Administration (FDA) has approved Credelio Quattro™ (lotilaner, moxidectin, praziquantel, and pyrantel chewable tablets), becoming the broadest approved canine oral parasiticide with its protection against six types of parasites—fleas, ticks, heartworms, and the three risky intestinal parasites—roundworms, hookwormsii and tapeworms.
AI Summary
Elanco Animal Health recently announced that the U.S. Food and Drug Administration (FDA) approved Credelio Quattro™, a new oral parasiticide designed to protect dogs against six types of parasites. This approval makes Credelio Quattro the broadest canine oral parasiticide available as it covers fleas, ticks, heartworms, roundworms, hookworms, and several tapeworm species.
The product is a single monthly chewable tablet intended for dogs eight weeks of age or older and is formulated with four active ingredients. These ingredients work together to provide comprehensive parasite protection, addressing increasing parasite pressure due to warmer temperatures and changing consumer habits. The FDA’s nod confirms the medication meets strict safety and efficacy standards, and its launch is expected in the first quarter of 2025, offering pet owners and veterinarians a first-of-its-kind solution for broad-spectrum parasite control.
Read Announcement- Drug:
- Credelio Quattro
- Announced Date:
- October 7, 2024
- Indication:
- lotilaner, moxidectin, praziquantel, and pyrantel chewable tablets monthly chewable tablet for dogs eight weeks of age or older.
Announcement
Credelio Quattro launch expected in first quarter of 2025
AI Summary
Elanco Animal Health has announced that Credelio Quattro, the first canine oral parasiticide protecting against six parasite types, is scheduled to launch in the first quarter of 2025. This innovative monthly chewable tablet is designed for dogs aged eight weeks and older and provides comprehensive coverage against fleas, ticks, heartworms, roundworms, hookworms, and tapeworms. The product addresses growing parasite challenges driven by warmer temperatures and evolving pet care practices, which have increased both animal and public health risks. Credelio Quattro unites four active ingredients to offer rapid protection, with studies showing fast and effective parasite control right from the first dose. By filling an important gap in parasite coverage, this new treatment promises pet owners and veterinarians a reliable, easy-to-use solution to safeguard pets and reduce the transmission of zoonotic parasites.
Read Announcement
Credelio® FDA Regulatory Timeline and Events
Credelio® is a drug developed by Elanco Animal Health for the following indication: For a prescription flea and tick.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Credelio®
- Announced Date:
- November 21, 2025
- Indication:
- For a prescription flea and tick
Announcement
Elanco Animal Health Incorporated announced it has received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for Credelio™ CAT (lotilaner) to treat New World screwworm (NWS) infestations in cats. This authorization represents the first EUA granted by the FDA for New World screwworm treatment in felines.
AI Summary
Elanco Animal Health announced the U.S. Food and Drug Administration has issued an Emergency Use Authorization (EUA) for Credelio CAT (lotilaner) to treat New World screwworm (NWS) infestations in cats and kittens. This is the first FDA EUA for NWS treatment in felines. The EUA permits emergency use but is not a full approval.
The EUA was based on studies indicating Credelio CAT may be effective against screwworm in cats. It is authorized only for the duration of the emergency declaration, and veterinarians should follow the EUA fact sheet when using the product.
With NWS detected near the U.S. border, the EUA gives vets and owners a ready treatment if the fly arrives. Preventing wounds—through year‑round flea and tick control and quick wound care—helps protect cats from screwworm infestation.
Read Announcement- Drug:
- Credelio®
- Announced Date:
- October 24, 2025
- Indication:
- For a prescription flea and tick
Announcement
Elanco Animal Health announced it has received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for Credelio™ (lotilaner) to treat New World screwworm (NWS) infestations in dogs.
AI Summary
Elanco Animal Health announced it has received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration for Credelio (lotilaner) to treat New World screwworm (NWS) infestations in dogs. This is the first-ever EUA for NWS in dogs, establishing a treatment option.
A study showed oral Credelio at the recommended dose cleared NWS larvae in infested dogs within 24 hours. The trial involved eleven dogs in Brazil and highlighted larval expulsion as the main action.
With NWS detected near the U.S.-Mexico border, the EUA ensures veterinarians and pet owners can use Credelio immediately if the fly enters the country.
Preventing open wounds is vital to avoid NWS myiasis. Flea and tick control, wound cleaning, and early veterinary care reduce entry points for screwworm eggs. Year-round parasite protection remains a key defense for dog health and safety.
Read Announcement- Drug:
- Credelio®
- Announced Date:
- August 15, 2024
- Indication:
- For a prescription flea and tick
Announcement
Parasites & Vectors, a leading peer-reviewed journal focused on parasites and vector-borne pathogens published the results of a head-to-head study demonstrating that Credelio, a prescription flea and tick protection product from Elanco Animal Health, has the fastest initial speed of tick kill in just 12 hours and sustains that advantage throughout the dosing interval.1,2,3
AI Summary
A recent study published in Parasites & Vectors found that Credelio, a prescription flea and tick product from Elanco Animal Health, kills ticks faster than its competitors. The head-to-head study compared Credelio with Simparica TRIO and NexGard for their speed in killing the lone star tick, a hard-to-kill tick known for its potential to spread diseases. The results showed that Credelio significantly reduced tick numbers within just 12 hours and maintained this rapid kill speed throughout the entire monthly treatment period. This sustained performance is important because the longer a tick remains attached, the higher the risk of transmitting dangerous pathogens to both pets and people. These findings support the recommendation for using fast-acting tick protection products to help prevent tickborne diseases in dogs.
Read Announcement
Zenrelia FDA Regulatory Timeline and Events
Zenrelia is a drug developed by Elanco Animal Health for the following indication: Treatment for canine allergic itch and inflammation.
This drug is approved by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Zenrelia
- Announced Date:
- September 23, 2025
- Indication:
- Treatment for canine allergic itch and inflammation
Announcement
Elanco Animal Health nnounced important updates to the U.S. Zenrelia label, following the Food and Drug Administration (FDA) review of supplemental scientific data.
AI Summary
Elanco Animal Health announced important updates to the U.S. Zenrelia label after the FDA reviewed new supplemental scientific data. The data have now been peer-reviewed and published, supporting the change.
The FDA concluded that “the totality of evidence supports removal of the risk of fatal vaccine-induced disease from modified live virus vaccines” from Zenrelia’s labeling. That language has been removed.
Elanco noted that the Boxed Warning still advises veterinarians to stop Zenrelia at least 28 days to three months before vaccination and to withhold it for at least 28 days afterward, due to the risk of an inadequate immune response.
This update brings the U.S. label in line with approvals in the EU, Great Britain, Brazil, and Japan. Elanco plans to generate additional data to further strengthen Zenrelia’s safety and efficacy information.
Read Announcement- Drug:
- Zenrelia
- Announced Date:
- July 24, 2025
- Indication:
- Treatment for canine allergic itch and inflammation
Announcement
Elanco Animal Health Incorporated announced that Zenrelia™ (ilunocitinib) has received approval by the European Commission.
Read Announcement- Drug:
- Zenrelia
- Announced Date:
- January 27, 2025
- Indication:
- Treatment for canine allergic itch and inflammation
Announcement
Elanco Animal Health Incorporated is introducing some of the first allergic dogs who have found zen and gotten back to normal by using Zenrelia.
AI Summary
Elanco Animal Health Inc. is highlighting a new treatment for allergic dogs called Zenrelia. This medication, approved by the FDA in September 2024, is helping alleviate itching and discomfort associated with skin allergies, allowing dogs to return to a more comfortable, normal life. In practice, dogs like Hunter, Trooper, Scrappy, and Buckaroo have experienced rapid relief. Hunter, for example, had struggled with constant licking and irritation for years, but after using Zenrelia, he now shows clear signs of improved comfort and well-being. Pet owners have shared similar stories of significant improvements in their dogs’ energy levels and overall happiness. Zenrelia, taken once daily, offers hope for many dog owners dealing with allergies, aiming to restore both the pet’s health and the bond between them and their owners.
Read Announcement- Drug:
- Zenrelia
- Announced Date:
- September 19, 2024
- Indication:
- Treatment for canine allergic itch and inflammation
Announcement
Elanco Animal Health announced the U.S. Food and Drug Administration (FDA) has approved Zenrelia™, a safe, highly effective, and convenient once-daily oral JAK inhibitor for control of pruritus (itching) associated with allergic dermatitis and control of atopic dermatitis in dogs at least 12 months of age.
AI Summary
Elanco Animal Health announced that the U.S. Food and Drug Administration (FDA) has approved Zenrelia™, a once-daily oral JAK inhibitor designed to treat pruritus related to allergic dermatitis and control atopic dermatitis in dogs aged 12 months and older. Zenrelia™ offers an effective and convenient treatment, helping to alleviate the chronic, acute, or seasonal itching that affects millions of dogs. By targeting the pathways that trigger allergic itch, Zenrelia™ not only provides quick relief but also helps prevent rebound itching, which is a common issue with other treatments. This approval marks an important milestone for canine dermatology by expanding treatment options available to veterinarians and pet owners, promising improved quality of life for dogs suffering from these skin conditions. Orders for Zenrelia™ have already started, with shipments expected to begin shortly.
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TruCan™ Ultra FDA Regulatory Events
TruCan™ Ultra is a drug developed by Elanco Animal Health for the following indication: Canine Influenza Vaccine.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- TruCan™ Ultra
- Announced Date:
- July 9, 2025
- Indication:
- Canine Influenza Vaccine
Announcement
Elanco Animal Health announced the U.S. Department of Agriculture (USDA) has approved TruCan Ultra CIV H3N2/H3N8, a canine influenza vaccine designed to provide broad respiratory disease protection.
Read Announcement
Bovaer FDA Regulatory Events
Bovaer is a drug developed by Elanco Animal Health for the following indication: for use in lactating dairy cattle.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Bovaer
- Announced Date:
- May 28, 2024
- Indication:
- for use in lactating dairy cattle.
Announcement
Elanco Animal Health announced the U.S. Food and Drug Administration (FDA) has completed its comprehensive, multi-year review of Bovaer® (3-NOP), a first-in-class methane-reducing feed ingredient, and determined the product meets safety and efficacy requirements for use in lactating dairy cattle.
AI Summary
Elanco Animal Health announced that the U.S. Food and Drug Administration has finished a comprehensive, multi‐year review of Bovaer® (3-NOP) and determined that it meets the safety and efficacy requirements for use in lactating dairy cattle. This first-in-class methane-reducing feed ingredient, when added to a cow’s diet, can cut methane emissions by about 30%, assisting dairy producers in achieving climate-neutral operations. The approval is expected to create a new revenue stream for dairy farmers through potential carbon credit opportunities. Elanco is preparing to launch Bovaer in the United States by the third quarter while also expanding its distribution to Canada and Mexico in partnership with dsm-firmenich. The review reflects the agency’s commitment to balancing rigorous scientific standards with the need to introduce innovative solutions that benefit both the environment and the dairy industry.
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