Primary source: Animal Drugs for New World Screwworm
The FDA has issued a new Emergency Use Authorization allowing Capstar and Nitenpyram Tablets to be used not only for treatment but now also for the prevention of New World screwworm infestations.
This EUA responds to an unmet need for preventive care against New World screwworm infestations, enhancing the tools available to veterinarians and pet owners. It aims to better protect pets, especially in areas at risk of NWS.
Update product labels to include prevention indications for Capstar and Nitenpyram Tablets. Ensure that labeling reflects new usage guidelines for these products as outlined in the Emergency Use Authorization.
Regulatory Intelligence Lead
Review in the next regulatory intelligence cycle.
Update product labels to include prevention indications for Capstar and Nitenpyram Tablets. Ensure that labeling reflects new usage guidelines for these products as outlined in the Emergency Use Authorization.
On September 3, 2026, the FDA issued an EUA for Capstar (nitenpyram) tablets and revised the EUA for Nitenpyram Tablets, allowing both products to be used for the prevention and treatment of New World screwworm (NWS) infections in dogs and cats. This marks the first authorization for prevention, addressing a significant need for pet owners and veterinarians. The products are available over the counter and dosage should be based on the animals' weight, with eligibility criteria including a minimum weight of two pounds and an age of at least four weeks.
What changed: The FDA has issued a new Emergency Use Authorization allowing Capstar and Nitenpyram Tablets to be used not only for treatment but now also for the prevention of New World screwworm infestations.
Why it matters: This EUA responds to an unmet need for preventive care against New World screwworm infestations, enhancing the tools available to veterinarians and pet owners. It aims to better protect pets, especially in areas at risk of NWS.
Practical implication: Update product labels to include prevention indications for Capstar and Nitenpyram Tablets. Ensure that labeling reflects new usage guidelines for these products as outlined in the Emergency Use Authorization.
Published from the regulator source ingestion pipeline after PV impact triage.
Review compliance with PREA obligations, prepare responses to any received non-compliance letters, and ensure any necessary deferral extension requests are properly submitted within the specified timeframe.
Healthcare establishments must quarantine the affected Eyefill C lots, refrain from using them, and monitor patients who received the device.
Users must ensure systems remain connected to power, conduct proper startup procedures, perform preoperative checks, and have emergency ventilation plans in place. Acknowledgment of receipt of the safety notice is required within 30 days.
Users are required to monitor inventory for affected lots and comply with instructions for potential disposal according to updated guidance from Microgenics Corporation.
