Parsippany, NJ – September 30, 2025 – Zoetis Inc. announced that Dectomax®-CA1 Injectable has received conditional approval from the U.S. Food and Drug Administration (FDA) for the prevention and treatment of New World screwworm (Cochliomyia hominivorax) infestations in cattle. This makes Dectomax®-CA1 the first and only parasite control product with conditional approval for this devastating livestock disease, covering beef cattle, female dairy cattle under 20 months, pregnant beef cows, newborn calves, and bulls. The conditional approval allows producers to use this targeted therapy while Zoetis completes full effectiveness studies, ensuring faster access to a critical animal health solution.
Science Significance
New World screwworm causes myiasis, a parasitic infestation that can result in severe tissue damage, secondary infections, and reduced livestock productivity. Dectomax®-CA1 utilizes doramectin, a well-established macrocyclic lactone, to deliver precise, potent activity against screwworm larvae, reducing the risk of reinfestation for up to 21 days. By targeting the larvae directly, the therapy exemplifies a precision-based veterinary approach, providing both preventive and therapeutic benefits. This advance is significant given that screwworm can spread rapidly, causing outbreaks that threaten herd health and animal welfare.
Regulatory Significance
Dectomax®-CA1 is the first screwworm treatment to gain conditional FDA approval, establishing an important precedent for regulatory pathways in veterinary parasitology. Conditional approval permits marketing of the product before full demonstration of long-term effectiveness, facilitating rapid deployment of essential therapies in situations of urgent animal health need. This milestone reflects Zoetis’ proactive collaboration with the FDA to ensure that innovative veterinary solutions are accessible while maintaining rigorous safety and efficacy oversight.
Business Significance
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The approval of Dectomax®-CA1 reinforces Zoetis’ global leadership in livestock health, particularly in parasite management. By introducing the first conditional screwworm treatment in the U.S., Zoetis demonstrates its strategic commitment to expanding high-value veterinary products. The launch complements Zoetis’ existing portfolio of vaccines, therapeutics, diagnostics, and technologies, enhancing the company’s position in providing integrated solutions for livestock producers worldwide. With this approval, Zoetis is well-positioned to support farmers in managing disease outbreaks, reducing economic losses, and maintaining herd health.
Patients’ Significance
New World screwworm infestation can lead to significant morbidity, mortality, and economic losses in affected herds. Dectomax®-CA1 offers a safe and effective preventive and treatment option, reducing both the immediate disease burden and long-term complications. By addressing infestations early and preventing reinfestation, the therapy helps producers maintain animal welfare, productivity, and sustainability of livestock operations, contributing to food security and economic stability in agricultural communities.
Policy Significance
The conditional approval aligns with broader public health and agricultural policy priorities emphasizing rapid access to effective therapies for high-impact livestock diseases. Swift availability of Dectomax®-CA1 can mitigate potential outbreaks of New World screwworm, protect the livestock industry from severe economic impact, and reinforce national biosecurity measures. Policies that support conditional approvals for critical veterinary products help ensure that innovative, life-saving interventions reach animals in need without undue regulatory delays.
Transaction Highlights
Zoetis’ conditional FDA approval of Dectomax®-CA1 Injectable represents a strategic advancement in livestock parasite management, marking the first and only product with conditional approval for prevention and treatment of New World screwworm (Cochliomyia hominivorax) infestations in cattle. The therapy leverages the proven doramectin formulation while extending its use to high-risk cattle populations, including beef herds, young dairy cows, pregnant cows, newborn calves, and bulls. This milestone underscores Zoetis’ commitment to innovation in veterinary therapeutics, enabling earlier access to a critical parasite control solution while completing full effectiveness studies. By addressing both treatment and prevention in a single product, Dectomax®-CA1 strengthens Zoetis’ leadership in parasite management and positions the company competitively in the rapidly evolving global veterinary market, enhancing its portfolio of integrated livestock health solutions and supporting economic resilience in agricultural production.
Source: Zoetis Inc. Press Release
