FDA Approves New Vet Drugs and Sponsor Shifts
Published Date: 4/16/2026
Rule
Summary
The FDA updated rules for new animal drugs approved in late 2025, including new approvals, withdrawals, and sponsor changes. These updates affect drug makers, vets, and pet owners by keeping drug info accurate and current starting April 16, 2026. No big cost changes, but everyone should note the new approvals and rule tweaks to stay in the know.
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Analyzed Economic Effects
9 provisions identified: 7 benefits, 1 costs, 1 mixed.
New CREDELIO QUATTRO approval and limits
The FDA added a new drug entry for CREDELIO QUATTRO (lotilaner, moxidectin, praziquantel, and pyrantel) effective April 16, 2026. The chewable tablets have specified strengths and are indicated to treat New World screwworm larvae in dogs and puppies 8 weeks of age and older and weighing 3.3 pounds or greater, and federal law restricts use to a licensed veterinarian.
Lotilaner labeled for fleas and ticks
The FDA revised lotilaner labeling to show it kills fleas and controls several tick species for one month in dogs and puppies 8 weeks of age and older and weighing 4.4 pounds or greater. The labeling also states that prevention of Borrelia burgdorferi (Lyme disease) is via killing the Ixodes scapularis tick, and federal law restricts use to or on the order of a licensed veterinarian.
New lymphoma drug for dogs (verdinexor)
The FDA added verdinexor tablets for treatment of lymphoma in dogs with specified tablet strengths and a dosing schedule: start at 1.25 mg/kg twice per week with at least 72 hours between doses and, if tolerated after 2 weeks, increase to 1.5 mg/kg twice per week. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
Pimobendan labeling for early heart disease in dogs
The FDA revised pimobendan labeling to allow use to delay onset of congestive heart failure in dogs with Stage B2 preclinical myxomatous mitral valve disease and to manage signs of congestive heart failure due to clinical MMVD or dilated cardiomyopathy, including use with concurrent therapies such as furosemide.
Turkey oxytetracycline withdrawal periods clarified
The FDA revised oxytetracycline powder entries to specify withdrawal periods for turkeys: withdraw 5 days prior to slaughter for products sponsored by Nos. 054771 and 061133, withdraw 4 days prior to slaughter for product sponsored by No. 016592, and zero-day withdrawal for products sponsored by Nos. 016592 and 069254.
Lincomycin feed approvals and swine treatment rules
The FDA updated lincomycin Type A and Type C feed entries for swine, including authorized concentrations and uses: examples include feed at 40 grams/ton for treatment programs, feed as sole ration at 100 grams/ton for 3 weeks to treat swine dysentery, 100–200 grams/ton for 21 days for respiratory disease, and a limitation that a pyrantel-containing feed not be used in swine that weigh more than 250 pounds and must be withdrawn 6 days before slaughter.
Cosyntropin injection approved for dogs
The FDA added cosyntropin injection for evaluation of adrenal function in dogs with a specified dose of 0.25 mg (1 mL) for dogs weighing 10 to 110 pounds (4.5 to 50 kg). The product is restricted to use by or on the order of a licensed veterinarian.
Lincomycin soluble powder approved uses including honey bees
The FDA revised lincomycin hydrochloride soluble powder directions, including a honey bee use: administer 100 mg lincomycin per hive once weekly for 3 weeks by mixing 250 mg soluble powder (100 mg lincomycin) with 20 g confectioners'/powder sugar and dusting over brood chamber top bars for control of American foulbrood.
Narasin and monensin labeling clarifies equine hazards
The FDA revised narasin and related entries to add or clarify limits and cautionary labeling that ingestion of narasin or monensin by horses, other equines, or certain other species has been fatal and that adult turkeys, horses, or other equines must not have access to these formulations.
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