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Elanco Animal Health (ELAN) FDA Events

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FDA Events for Elanco Animal Health (ELAN)

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 Bovaer, Credelio, Credelio®, TruCan™, and Zenrelia. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.

Elanco Animal Health's Drugs in FDA Review

Bovaer - FDA Regulatory Timeline and 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.

Credelio Quattro - FDA Regulatory Timeline and Events

Credelio Quattro is a drug developed by Elanco Animal Health for the following indication: lotilaner, moxidectin, praziquantel, and pyrantel chewable tablets monthly chewable tablet for dogs eight weeks of age or older. This drug is approved by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

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.

TruCan™ Ultra - FDA Regulatory Timeline and 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.

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.

Elanco Animal Health FDA Events - Frequently Asked Questions

Yes, Elanco Animal Health (ELAN) has received FDA approval for multiple therapies, including Credelio Quattro and Zenrelia. This page tracks recent and historical FDA regulatory events related to Elanco Animal Health's drug portfolio.

In the past two years, Elanco Animal Health (ELAN) has reported FDA regulatory activity for the following drugs: Zenrelia, Credelio Quattro, TruCan™ Ultra, Credelio® and Bovaer.

The most recent FDA-related event for Elanco Animal Health occurred on July 9, 2025, involving TruCan™ Ultra. The update was categorized as "Approved," with the company reporting: "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."

Current therapies from Elanco Animal Health in review with the FDA target conditions such as:

  • Treatment for canine allergic itch and inflammation - Zenrelia
  • lotilaner, moxidectin, praziquantel, and pyrantel chewable tablets monthly chewable tablet for dogs eight weeks of age or older. - Credelio Quattro
  • Canine Influenza Vaccine - TruCan™ Ultra
  • For a prescription flea and tick - Credelio®
  • for use in lactating dairy cattle. - Bovaer

More FDA Event Resources from MarketBeat

  • NDA: New Drug Application
  • ANDA: Abbreviated New Drug Application
  • sNDA: Supplemental New Drug Application
  • BLA: Biologics License Application
  • sBLA: Supplemental Biologics License Application
  • FDA Approved: Approved by the FDA
  • EMA: European Medicines Agency
  • CE Mark: European Union Certification
  • NMPA: China National Medical Products Administration
  • MHLW: Japanese Ministry of Health
  • FDA Meeting: Consultation with FDA
  • Pre-IND: Pre-Investigational New Drug Meeting
  • Breakthrough Therapy: Special FDA designation for promising therapies
  • Fast Track: Accelerated FDA approval pathway
  • Orphan Drug: Designation for rare disease treatments
  • RPD: Rare Pediatric Disease Designation
  • RMAT: Regenerative Medicine Advanced Therapy
  • DSMB Review: Data Safety Monitoring Board Review
  • IDMC Review: Independent Data Monitoring Committee
  • MAA: MHRA Marketing Authorization Application
  • RTF: Refusal to File (Rejected Application)
  • 510(k): FDA Clearance for Medical Devices
  • Rolling Submission: Staggered regulatory review process

This page (NYSE:ELAN) was last updated on 7/10/2025 by MarketBeat.com Staff
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