Zoetis Gains FDA Nod for First U.S. Screwworm Cattle Drug
Conditional approval for Dectomax-CA1 addresses a significant threat to the U.S. livestock industry, boosting company shares.
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 drug is the first of its kind in the United States for the prevention and treatment of New World screwworm infestations in cattle, a potentially devastating agricultural threat. News of the approval sent company shares up 2.28% in trading.
The conditional approval allows Zoetis to bring the treatment to market while it gathers additional effectiveness data required for full approval. The FDA granted this accelerated status because the drug addresses a serious and unmet animal health need. According to the , Dectomax-CA1 is intended to prevent reinfestation for up to 21 days, providing a critical tool for ranchers to protect their herds.
Screwworms are fly larvae that consume the living tissue of warm-blooded animals, and an outbreak could have severe economic consequences for the U.S. cattle industry. The FDA's action provides a vital defensive measure against this parasite. The approval process was streamlined because Dectomax-CA1 contains the same active ingredient, doramectin, as Zoetis's fully approved Dectomax, leveraging existing safety and manufacturing data.
Investor reaction was positive, with the stock closing at $146.32 on the day of the announcement. The move was notable as ZTS had been trading near its 52-week low, suggesting the regulatory news could serve as a catalyst for the animal health giant. The underscores the product's importance in national agricultural biodefense.
Zoetis expects to have updated labeling for Dectomax Injectable bottles that includes the new Dectomax-CA1 indications available in the first half of 2026. The conditional approval stands for one year and can be renewed annually for up to four additional years as the company works toward completing its final data package.