---
title: "FDA EUA Authorizes Capstar and Nitenpyram for Prevention and Treatment of New World Screwworm in D"
id: "fda-news-releases-1-fda-issues-emergency-use-authorization-for-drugs-to-prevent-and-treat-new-world"
canonical_url: "https://medichelpline.com/clinical-feed/fda-news-releases-1-fda-issues-emergency-use-authorization-for-drugs-to-prevent-and-treat-new-world"
content_type: "clinical_feed_article"
specialty: "General"
source_name: "FDA News Releases"
source_url: "http://www.fda.gov/news-events/press-announcements/fda-issues-emergency-use-authorization-drugs-prevent-and-treat-new-world-screwworm-dogs-and-cats"
published_at: "2026-09-03T15:01:02.000Z"
evidence_level: "Agency Feed"
license: "CC-BY-NC-4.0 / Informational Use"
---
# FDA EUA Authorizes Capstar and Nitenpyram for Prevention and Treatment of New World Screwworm in D
## Provenance & Clinical Metadata
- **Canonical URL:** https://medichelpline.com/clinical-feed/fda-news-releases-1-fda-issues-emergency-use-authorization-for-drugs-to-prevent-and-treat-new-world
- **Specialty:** [General](https://medichelpline.com/clinical-feed/general.md)
- **Primary Source:** FDA News Releases
- **Source URL:** [Original Journal Publication](http://www.fda.gov/news-events/press-announcements/fda-issues-emergency-use-authorization-drugs-prevent-and-treat-new-world-screwworm-dogs-and-cats)
- **Published At:** 2026-09-03T15:01:02.000Z
- **Evidence Rating:** Agency Feed
## Executive GIST (TL;DR)
- The FDA issued an Emergency Use Authorization (EUA) expanding use of **Capstar (nitenpyram)** and revising the EUA for generic **Nitenpyram Tablets** to allow both prevention and treatment of **New World screwworm (NWS)** myiasis in dogs, puppies, cats, and kittens weighing at least two pounds and at least four weeks old. - Nitenpyram Tablets had previously been authorized in June 2026 for treatment only; the new action adds authorization for prevention as well. - The FDA said the decision was based on the totality of scientific evidence and that it is reasonable to believe the products may be effective for prevention and treatment of NWS when used as authorized, with benefits outweighing known and potential risks. - Most U.S. pets are at low risk because confirmed NWS cases are limited geographically, but animals living in, traveling to, or returning from affected areas or certain countries south of the U.S. border should be closely monitored for signs such as visible maggots or foul odors in wounds or body openings. - Capstar and Nitenpyram Tablets are available over the counter in 11.4 mg and 57 mg tablet sizes; dosing is weight-based. They should not be given to pets under two pounds or younger than four weeks. - Pet owners and veterinarians are directed to review the products’ EUA Fact Sheets, FOI Summaries, and Letters of Authorization for detailed use information; these materials are available on the FDA’s New World Screwworm emergency information page. - The EUAs remain in effect until revoked or until the HHS Secretary terminates the declaration that justified emergency use. Sponsors are Sergeant’s Pet Care Products LLC (Capstar) and Felix Pharmaceuticals Pvt. Ltd. (Nitenpyram Tablets). - For U.S. case updates, the FDA directs readers to the U.S. Department of Agriculture’s Confirmed Detections of New World Screwworm dashboard. - Timothy Schell, Ph.D., director of the FDA’s Center for Veterinary Medicine, noted the authorization addresses a previously unmet need by enabling prevention options for pet owners and veterinarians.
## Clinical Analysis & Structured Key Points
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[Home](https://www.fda.gov/) 2. [News & Events](https://www.fda.gov/news-events) 3. [FDA Newsroom](https://www.fda.gov/news-events/fda-newsroom) 4. [Press Announcements](https://www.fda.gov/news-events/fda-newsroom/press-announcements) 5. FDA Issues Emergency Use Authorization for Drugs to Prevent and Treat New World Screwworm in Dogs and Cats 1. [ Press Announcements ](https://www.fda.gov/news-events/fda-newsroom/press-announcements "Press Announcements") [In this section](https://www.fda.gov/news-events/press-announcements/fda-issues-emergency-use-authorization-drugs-prevent-and-treat-new-world-screwworm-dogs-and-cats#section-nav) * [ Press Announcements ](https://www.fda.gov/news-events/fda-newsroom/press-announcements "Press Announcements") FDA News Release # FDA Issues Emergency Use Authorization for Drugs to Prevent and Treat New World Screwworm in Dogs and Cats [ More Press Announcements](https://www.fda.gov/news-events/newsroom/press-announcements) For Immediate Release: September 03, 2026 The U.S. Food and Drug Administration today issued an Emergency Use Authorization (EUA) for Capstar (nitenpyram) tablets and revised the EUA for Nitenpyram Tablets, the generic version of Capstar, to authorize both products for the prevention and treatment of New World screwworm (NWS) infestations (myiasis) in dogs, puppies, cats, and kittens that weigh at least two pounds and are at least four weeks old. Nitenpyram Tablets were initially authorized in June 2026 for treatment only. “Although the FDA has authorized or conditionally approved multiple products for the treatment of New World screwworm in dogs and cats, none were for prevention – until today,” **said Timothy Schell, Ph.D., director of the FDA’s Center for Veterinary Medicine**. “The FDA is addressing a previously unmet need and giving pet owners and veterinarians important tools to protect dogs and cats from NWS infestations.” Currently, most dogs and cats in the U.S. are at low risk of NWS exposure because confirmed cases of NWS are in a limited geographic region. However, dogs and cats that live in, travel to, or return from areas where NWS infestations have been identified by state or federal animal health officials, as well as certain countries south of the U.S. border, should be closely monitored for signs of infestation, such as visible maggots or foul odors in wounds or body openings (e.g., eyes, ears, nose, mouth). Seek immediate veterinary care for infested dogs and cats. For up-to-date U.S. case information, see the U.S. Department of Agriculture’s dashboard of [Confirmed Detections of New World Screwworm](https://www.aphis.usda.gov/animals/animal-health/livestock-and-poultry-disease/current-status/us-confirmed-cases-new-world). Based on the totality of the scientific evidence available, the FDA has concluded it is reasonable to believe that Capstar and Nitenpyram Tablets may be effective in the prevention and treatment of NWS myiasis in certain dogs, puppies, cats, and kittens when used as authorized, and the known and potential benefits of the products outweigh their known and potential risks. Capstar and Nitenpyram Tablets are available over the counter and come in two tablet sizes: 11.4 and 57 mg. Dosage is based on a dog’s or cat’s weight. Do not administer to pets less than two pounds or younger than four weeks old. For detailed information about how to use these products, pet owners should carefully review the relevant product’s fact sheet. All EUA product Fact Sheets, FOI Summaries, and Letters of Authorization are available on [Emergency Use Authorization of Animal Drugs for NWS](https://www.fda.gov/animal-veterinary/safety-health/new-world-screwworm-information-veterinarians#Emergency). These EUAs will be in effect until they are revoked or the HHS Secretary terminates the [declaration](https://www.federalregister.gov/documents/2025/08/20/2025-15918/declaration-of-emergency-pursuant-to-the-federal-food-drug-and-cosmetic-act-for-new-world-screwworm) that the potential public health emergency presented by NWS justifies the emergency use authorization of animal drugs for NWS. Capstar is sponsored by Sergeant’s Pet Care Products LLC of Omaha, Nebraska, and Nitenpyram Tablets are sponsored by Felix Pharmaceuticals Pvt. Ltd. based in Ireland. ## Related Information Related Information * [Animal Drugs for New World Screwworm](https://www.fda.gov/animal-veterinary/safety-health/animal-drugs-new-world-screwworm) * [Emergency Use Authorization of Animal Drugs for NWS](https://www.fda.gov/animal-veterinary/safety-health/new-world-screwworm-information-veterinarians#Emergency) * [Screwworm.gov – Unified Government Response to Protect the United States](https://www.screwworm.gov/) * * * **Media:** [FDA Request for Comment](https://www.hhs.gov/request-for-comment-form/index.html?Agency=FDA) 202-690-6343 **Consumer:** 888-INFO-FDA ### Boilerplate The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. 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