FDA & Biotech

Zoetis Gains FDA Nod for First-of-its-Kind Cattle Drug

Conditional approval for Dectomax-CA1 targets New World screwworm, opening a new, exclusive market for the animal health giant.

Zoetis Inc. (NYSE: ZTS) has secured a significant regulatory win, receiving conditional approval from the U.S. Food and Drug Administration (FDA) for its Dectomax-CA1 injectable solution. The decision marks a critical milestone, making it the first and only product approved to treat and prevent infestations from the New World screwworm in cattle, a serious and often life-threatening condition.

The approval carves out a new and exclusive market segment for the $64 billion animal health company, addressing a previously unmet need in the livestock industry. , the drug is approved for a broad range of cattle, including calves and pregnant cows, and is expected to be commercially available in the first half of 2026.

The FDA granted the conditional approval based on the drug's potential to manage a life-threatening disease and the complexities involved in conducting full-scale effectiveness studies for this specific parasite. Dectomax-CA1 uses doramectin, the same active ingredient as its predecessor, Dectomax Injectable, providing a familiar foundation for veterinarians and producers.

This regulatory catalyst arrives as Zoetis demonstrates strong financial health. The company recently surpassed quarterly earnings expectations, reporting $1.76 earnings per share against a consensus estimate of $1.62, and has raised its full-year revenue guidance for 2025. The positive news has been reflected in market sentiment, with on the company's stock. While some analysts have slightly adjusted price targets, the overall outlook remains positive, with an average target suggesting significant potential upside from its current trading price.

The approval of Dectomax-CA1 not only strengthens Zoetis's portfolio of livestock treatments but also reinforces its market leadership position in the animal health sector. As the sole provider of a solution for New World screwworm, the company is poised to capture a dedicated revenue stream while providing a vital tool for cattle producers across the United States. the company's robust pipeline and consistent performance as key drivers for future growth.