Zoetis (ZTS) FDA Events

Zoetis' Drug in the FDA Approval Process

This section highlights FDA-related milestones and regulatory updates for drugs developed by Zoetis (ZTS). Over the past two years, Zoetis has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as Librela. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.

Librela FDA Regulatory Events

Librela is a drug developed by Zoetis for the following indication: For Canine Osteoarthritis (OA) Pain. 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.

Provided Update - February 4,2025

• Drug: Librela
• Announced Date: February 4, 2025
• Indication: For Canine Osteoarthritis (OA) Pain

Zoetis Inc announced that it has updated the U.S. label for Librela® (bedinvetmab injection), following its submission of a supplement to the U.S. Food and Drug Administration (FDA).

Zoetis Inc. announced that it has updated the U.S. label for Librela® (bedinvetmab injection) after submitting a supplement to the FDA. This update is based on real-world post-approval experience with the product since its U.S. launch in October 2023. The revised label reflects additional data collected on the safety and effectiveness of Librela, a once-monthly injectable treatment designed to help manage pain from osteoarthritis in dogs. Zoetis plans to implement the updated label immediately by making it available on its website and providing it to veterinarians, as part of its commitment to ensuring informed decision-making for pet owners and veterinary professionals. The company’s actions underline its dedication to continually monitoring customer feedback and real-world data to enhance the safe use of Librela in treating more than one million dogs in the U.S.

Zoetis FDA Events - Frequently Asked Questions

Has Zoetis received FDA approval?

As of now, Zoetis (ZTS) has not received any FDA approvals for its therapy in the last two years.

What drugs has Zoetis submitted to the FDA?

In the past two years, Zoetis (ZTS) has reported FDA regulatory activity for Librela.

What is the most recent FDA event for Zoetis?

The most recent FDA-related event for Zoetis occurred on February 4, 2025, involving Librela. The update was categorized as "Provided Update," with the company reporting: "Zoetis Inc announced that it has updated the U.S. label for Librela® (bedinvetmab injection), following its submission of a supplement to the U.S. Food and Drug Administration (FDA)."

What conditions do Zoetis' current drugs treat?

Currently, Zoetis has one therapy (Librela) targeting the following condition: For Canine Osteoarthritis (OA) Pain.