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Investing.com -- Zoetis Inc (NYSE:ZTS) stock rose 2.4% on Tuesday after the U.S. Food and Drug Administration conditionally approved the company’s drug for the prevention and treatment of New World screwworm infestations in cattle.
The FDA granted conditional approval for Dectomax-CA1, an injectable solution containing doramectin, making it the first approved drug in the U.S. for New World screwworm (NWS). The medication will prevent and treat NWS larval infestations and prevent reinfestation for up to 21 days in cattle.
"We understand the urgency with which America’s farmers and ranchers are asking for tools to fight New World screwworm," said FDA Commissioner Marty Makary in the announcement. "Today’s conditional approval – the first in the U.S. for NWS – shows our dedication to rapidly advancing important animal medicines when they are needed most."
The drug received conditional approval because it addresses a serious disease and an unmet animal health need, while demonstrating its effectiveness would require complex studies. Under this status, the FDA determined the drug is safe with a reasonable expectation of effectiveness.
Dectomax-CA1 contains the same active ingredient as Zoetis’s already-approved Dectomax product, which is used to treat certain nematode and arthropod parasites in cattle and swine. The conditional approval allows cattle producers immediate access to the treatment while Zoetis collects additional data needed for full approval.
The Michigan-based animal health company’s drug will be available in 250 mL and 500 mL bottles, with a 35-day withdrawal period required before treated cattle can enter the food supply.
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