FDA approves first generic drug for hyperthyroidism in cats

The Food and Drug Administration (FDA) has recently approved several animal drugs, including those that treat hyperthyroidism in cats and urinary incontinence in dogs. In addition, the agency is advising veterinarians and pharmacists to use Bimasone, a flumethasone injectable solution, instead of unapproved drugs in their patients.

Felanorm

On July 9, the FDA announced it had approved Felanorm, the first generic methimazole oral solution for the treatment of hyperthyroidism in cats.

Felanorm contains 5 mg of methimazole per 1 mL of solution while the approved brand name drug product, Felimazole Coated Tablets, come in 2.5 mg and 5 mg tablet sizes. Felimazole was first approved in 2009.

The new generic antithyroid drug, available only by prescription from a licensed veterinarian, needs continued veterinary monitoring to ensure that the dose continues to be appropriate to control the cat's hyperthyroidism, according to the FDA.

Felanorm is supplied in 30- or 100-mL bottles with a 1 mL dosing syringe. It is dosed in 2.5 mg increments, every 12 hours. Dose adjustments should be made in 2.5 mg increments. The maximum total dosage is 20 mg per day divided, not to exceed 10 mg as a single administration.

Felanorm is the first generic Food and Drug Administration-approved methimazole oral solution for the treatment of hyperthyroidism in cats. (Courtesy of Norbrook Laboratories Ltd.)

People administering the drug should wear protective single-use, impermeable gloves and wash their hands with soap and water afterward to avoid exposure to the drug.

Felanorm is sponsored by Norbrook Laboratories Ltd., based in the United Kingdom.

MoxiSolv Injection

The FDA announced on July 2 it had approved MoxiSolv Injection, a generic moxidectin injectable solution, for beef and nonlactating dairy cattle. The antiparasitic is used for the treatment and control of internal and external parasites of cattle, including gastrointestinal roundworms, lungworms, cattle grubs, mites, and lice.

The drug contains the same active ingredient, moxidectin, in the same concentration and dosage form as the brand-name drug product, Cydectin, first approved for use in beef and nonlactating cattle in 2005.

MoxiSolv is supplied in 200- or 500-mL multi-dose bottles. It is available over the counter and is administered by injection at a dosage of 1 mL for each 110 lb (50 kg) body weight. Each mL contains 0.2 mg of moxidectin, sufficient to treat 2.2 lb (0.2 mg/kg) of body weight.

Data demonstrate that residues in food products derived from beef and nonlactating dairy cattle treated with MoxiSolv Injection will not represent a public health concern if the product is used properly.

MoxiSolv is sponsored by Bimeda Animal Health Ltd., based in Dublin.

Trimeprazine with Prednisolone

On June 20, the FDA announced approval of Trimeprazine with Prednisolone tablets as an antipruritic and antitussive for dogs with itch and cough conditions. This is the first generic trimeprazine with prednisolone tablets for dogs. The tablets are bioequivalent to the brand-name drug product, Temaril-P.

This antihistamine and corticosteroid reduces the inflammation commonly associated with most skin disorders of dogs such as the eczema caused by internal disorders, otitis, and dermatitis.

Trimeprazine with prednisolone is recommended for the treatment of canine infectious respiratory disease complex, also known as "kennel cough," or tracheobronchitis, bronchitis, and infections of nonspecific origin.

The drug is available by prescription in 100- and 1000-count bottles. Each tablet contains 5 mg trimeprazine as trimeprazine tartrate and 2 mg prednisolone. The initial dosage regimen depends on the dog's weight:

• Up to 10 lb receive half a tablet, twice daily
• 11 - 20 lb receive one tablet, twice daily
• 21 - 40 lb receive two tablets, twice daily
• Over 40 lb receive three tablets, twice daily

After four days, the dosage is reduced to half of the initial dose or an amount that is enough to maintain remission of symptoms.

Timeprazine with prednisolone is sponsored by ZyVet Animal Health, Inc., based in Pennington, New Jersey.

Phenylpropanolamine hydrochloride

The FDA announced June 11 it had approved the first generic drug for the control of urinary incontinence due to urethral sphincter hypotonus in dogs.

Phenylpropanolamine hydrochloride chewable tablets contain the same active ingredient in the same concentration and dosage form as the approved brand name drug product, Proin chewable tablets, which were first approved in 2011.

The generic version, available by prescription from a licensed veterinarian, comes in 25, 50 and 75 mg half-scored chewable tablets and comes with 60 or 180 count bottles. The dosage should be calculated in half-tablet increments and should be administered orally at a total daily dose of 2 mg/kg (0.91 mg/lb) of body weight twice daily.

Phenylpropanolamine hydrochloride chewable tablets are sponsored by ZyVet Animal Health Inc., based in Pennington, New Jersey.

Safe-Guard

On May 23, the FDA issued a supplemental approval for Safe-Guard, an anthelmintic containing fenbendazole, for the treatment of gastrointestinal worms (Aulonocephalus spp.) in wild quail.

This is the first animal drug approval for use in wild quail.

Some of the studies that supported the approval of Safe-Guard in wild quail were conducted by the U.S. Department of Agriculture's Minor Use Animal Drug Program in collaboration with researchers from Texas Tech Wildlife Toxicology Laboratory.

The FDA determined that fenbendazole is safe and effective, and that there is a reasonable certainty of no harm for residues of fenbendazole in the edible tissues of treated quail following human consumption. Fenbendazole is marketed as a Type A medicated article but can be used in the manufacture of Type B and Type C medicated feeds.

Wild quail should be administered 90.7g of fenbendazole per ton of Type C medicated feed, to be fed for 21 consecutive days. Safe-Guard is available over the counter and is supplied in 25-pound bags.

The drug was previously approved for the treatment of certain intestinal parasites in other animal species, such as cattle, swine, and turkeys.

Safe-Guard is sponsored by Intervet Inc., based in Rahway, New Jersey.

Bimasone letters

On July 10, the FDA sent a "Dear Veterinarian" letter advising practitioners to use Bimasone, a flumethasone injectable solution, instead of unapproved drugs in their patients. The same day, the FDA sent a "Dear Pharmacy Professional" letter advising pharmacies to dispense Bimasone instead of unapproved drugs for animal patients.

The FDA approved Bimasone in April 2023 for use in horses, dogs, and cats for the various rheumatic, allergic, dermatologic, and other conditions known to be responsive to anti-inflammatory corticosteroids.

Bimasone is the first generic flumethasone product to receive FDA approval. It contains the same active ingredient, flumethasone, in the same concentration and dosage form as the approved brand name drug product, Flucort.

Bimasone is available by prescription from a licensed veterinarian and is supplied in a 0.5-mg/mL concentration in 100-mL multi-dose vials. Approved dosage regimens vary by species and circumstance. Unapproved flumethasone products should not be imported from other countries for use in animal patients, according to the agency. Any compounded animal drug, including a compounded flumethasone product, is not FDA-approved.

"Unlike FDA-approved Bimasone, compounded and other unapproved formulations of flumethasone have not been evaluated by the FDA for safety or effectiveness and may vary in quality. It is especially important for injectable medications, such as flumethasone, to be sterile," the Letter to Veterinarian stated.

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