Thursday, December 4, 2025

FDA Conditionally Approves Topical Drug for Cattle for New World Screwworm and Cattle Fever Tick

 

Today, the U.S. Food and Drug Administration conditionally approved Exzolt Cattle-CA1 (fluralaner) topical solution for the prevention and treatment of New World screwworm (NWS) larval infestations, and the treatment and control of cattle fever tick in beef cattle 2 months of age and older and replacement dairy heifers less than 20 months of age.

“This conditional approval gives cattle producers a new tool to combat two parasites threatening the well-being of cattle in the U.S.,” said FDA Commissioner Marty Makary, M.D., M.P.H. “Although NWS has not been detected in the U.S., cattle fever tick is here. This is the first drug conditionally approved by the FDA specifically for the control and treatment of cattle fever tick.”

This conditional approval means the FDA has determined Exzolt Cattle-CA1 is safe and has a reasonable expectation of effectiveness for its intended use. The sponsor, Intervet, Inc. of Rahway, New Jersey, has up to five years to generate the additional effectiveness data needed to support a full FDA approval.  

“The FDA is leveraging every resource and authority at its disposal to ensure producers and veterinarians have the critical products they need to protect their livestock and safeguard our food supply against NWS and cattle fever tick,” said Timothy Schell, Ph.D., director of the FDA’s Center for Veterinary Medicine. “We remain steadfast in our commitment to ensuring that animal drugs are safe and effective and that food from treated animals is safe to eat.”

Exzolt Cattle-CA1 is eligible for conditional approval because it is intended to prevent and treat serious or life-threatening diseases in cattle, it addresses unmet animal health needs, and demonstrating effectiveness of the drug requires complex or particularly difficult studies. Exzolt Cattle-CA1 received expedited review through a priority zoonotic animal drug (PZAD) designation, an authority provided to the FDA under the Coronavirus Aid, Relief, and Economic Security (CARES) Act.

To prevent unsafe drug residues in meat from treated cattle and ensure human food safety, the slaughter withdrawal period for Exzolt Cattle-CA1 is 98 days. This product is not for use in lactating dairy cattle, dairy calves, veal calves, or bulls at least 1 year old that are intended for breeding.

Exzolt Cattle-CA1 topical solution is available by prescription only and dispensed in 250 mL, 1L and 5L bottles. The single-use, ready-to-use product is applied directly to the hair and skin in a narrow strip extending along the top of a bovine’s back from between the shoulder blades to the base of the tail (withers to tailhead along the dorsal midline).

Antiparasitic drugs such as Exzolt Cattle-CA1 should be used only when medically necessary, in accordance with the product labeling, and as part of a comprehensive parasite management strategy.


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Wednesday, December 3, 2025

 

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Warning Letters to Compounding Pharmacies

 

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Certain bodybuilding and ayurvedic products put consumers at risk 

FDA is concerned about the potential health risks associated with products that claim to treat a variety of health issues or conditions. Consumers should avoid products marketed as supplements or other types of products that claim to have effects similar to prescription drugs.  

These products are a waste of money and there is no guarantee these fraudulent products will work as they claim they will. Many of these products pose a serious risk to your health and can have life-threatening outcomes. Bottom line: If it seems too good to be true, it probably is. 

Learn More

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Tuesday, December 2, 2025

FDA Seizes 7-OH Opioids to Protect American Consumers; seizure focused on foods and dietary supplement products—including liquid shots and tablets—

 The U.S. Food and Drug Administration, in coordination with the U.S. Department of Justice, announced today that the U.S. Marshals Service seized approximately 73,000 units of 7-hydroxymitragynine (7-OH) products—valued at roughly $1 million—from three firms in Missouri.

The seizure focused on foods and dietary supplement products—including liquid shots and tablets—containing concentrated 7-OH as an added ingredient. Concentrated 7-OH is increasingly recognized as having potential for abuse because of its ability to bind to opioid receptors. It cannot be lawfully added to dietary supplements or conventional foods. These products are considered adulterated because 7-OH does not meet applicable safety standards. Also, the FDA has not approved 7-OH for medical use.

“This enforcement action is a strong step to protect Americans from the dangers of concentrated 7-OH products, which are potent opioids,” said FDA Commissioner Marty Makary, M.D., M.P.H. “We must be proactive and vigilant to address emerging threats to our communities and our kids.”

The FDA worked closely with the Missouri Department of Health and Senior Services in this enforcement action, which builds on the FDA’s comprehensive efforts to protect Americans from dangerous, illegal opioid substances. In July of this year, the FDA recommended the scheduling of certain 7-OH products under the Controlled Substances Act and issued warning letters to companies for illegally distributing products containing 7-OH, including tablets, gummies, drink mixes and shots. FDA also notified health care professionals and informed consumers of the risks associated with concentrated 7-OH products.

“The rise in the use of concentrated 7-OH as an illegal ingredient in foods and dietary supplements is of particular concern for the FDA,” said FDA Deputy Commissioner for Human Foods, Kyle Diamantas, J.D. “Actions like those announced today put a marker down that our agency will not tolerate the use of this dangerous ingredient in foods and dietary supplements, especially in products that are accessible to our nation’s youth.”

These recent operations demonstrate coordinated federal enforcement efforts against concentrated 7-OH products. The FDA reminds all manufacturers and distributors that they must ensure their products comply with all applicable federal requirements.

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PBM Reforms: Are Sweeping Changes in Store for a Much-Maligned Industry?
On the surface, the chief factors behind the perennially escalating costs of prescription drugs consumed by Americans appear to be threefold: pharmaceutical companies, ...
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Wednesday, November 19, 2025

 

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