Generic drugs for treating inflammation, vomiting, parasites receive FDA approval
The Food and Drug Administration announced in March and April that it had approved six generic animal drugs.
The agency approved Bimasone, the first generic flumethasone (PDF) indicated for certain diseases that cause inflammation in horses, dogs, and cats.
Bimasone is an injectable corticosteroid drug. It contains the same active ingredient, flumethasone, in the same concentration and dosage form as the approved brand name drug product, Flucort. Flucort was first approved for use in horses, dogs, and cats in 1965.
In horses, Bimasone is approved for use for musculoskeletal conditions involving inflammation, such as bursitis, carpitis, osselets, and myositis.
In dogs, Bimasone is approved for use for conditions involving inflammation of muscles or joints, such as arthritis, osteoarthritis, intervertebral disk disease, and myositis. The drug has proven useful in treating ear infections (otitis externa) in dogs when used with topical medication. It is also approved for certain acute and chronic skin conditions to help control the itchy skin (pruritus), irritation, and inflammation associated with these conditions, and for use in treating allergic reactions and insect bites. Bimasone also is approved for treating shock in dogs, when administered intravenously.
In cats, Bimasone is approved for certain acute and chronic skin conditions to help control pruritus, irritation, and inflammation.
The drug 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.
Bimasone is sponsored by Bimeda Animal Health Ltd., based in Dublin, Ireland.
The FDA approved two versions of Modulis, a generic cyclosporine oral solution, for the control of allergic dermatitis in cats and the control of atopic dermatitis in dogs.
Modulis for Cats (PDF) is the first generic modified cyclosporine oral solution indicated for the control of feline allergic dermatitis, as manifested by scratching-induced skin abrasions, miliary dermatitis, eosinophilic plaques, and self-induced hair loss. It is intended for cats at least 6 months old, weighing at least 3 lb (1.4 kg).
Modulis for Cats is an immunosuppressant drug that suppresses the allergic process that makes cats with allergic dermatitis itchy. It contains the same active ingredient, cyclosporine, in the same concentration and dosage form—100 mg/mL—as the approved brand-name drug product, Atopica for Cats, which was first approved in 2011.
The initial dosage of Modulis for Cats is 7 mg/kg (3.2 mg/lb), orally, once daily for a minimum of four to six weeks, or until clinical sign resolve. The product is supplied in 4.7-, 15-, and 30-mL bottles, and comes with an oral dosing syringe.
Modulis for Dogs is the generic drug indicated for the control of atopic dermatitis in dogs weighing at least 4 lb (1.8 kg).
The product comes as an oral solution containing 100 mg/mL of the same active ingredient, cyclosporine, as the approved brand-name drug product, Atopica, which comes as a gelatin capsule containing cyclosporine solution in various doses. Atopica was first approved for use in dogs in 2019 and a generic equivalent, Cyclavance, was approved in 2020.
Modulis for Dogs is supplied in 4.7-, 15-, 30-, and 50-mL bottles, along with oral dosing syringes.
The initial dosage of Modulis for Dogs is 5 mg/kg (2.3 mg/lb), orally, once daily for 30 days. For dogs weighing 4-40 lb (1.8 to 18.2 kg), the 1-mL syringe is to be used, with the 3-mL syringe used for dogs weighing 41-125 lb (18.6 to 62.5 kg).
Both versions of Modulis are available by prescription from a licensed veterinarian. People handling, administering, or exposed to either product should take precautions to avoid accidentally ingesting the drug, such as not eating or drinking while handling it. Users also should wash their hands after administering the drug.
Modulis is sponsored by Provetica LLC, based in Lenexa, Kansas.
Maropitant citrate tablets
The FDA approved generic maropitant citrate tablets (PDF) for dogs for the prevention of acute vomiting and of vomiting due to motion sickness.
These generic tablets are an antiemetic drug that contains the same active ingredient, maropitant citrate, in the same concentration and dosage form as the approved brand-name drug product, Cerenia tablets, which was first approved in 2007.
The tablets are available in 16-, 24-, 60-, or 160-mg doses. Each tablet is scored and packaged in blister packs containing four tablets per perforated sheet. This generic drug is available by prescription from a licensed veterinarian.
The tablets should be administered orally at a minimum dose of 2 mg/kg (0.9 mg/lb). For prevention of acute vomiting, they are to be given either once daily for up to five days (dogs 2-7 months old) or daily until vomiting resolves (dogs 7 months and older).
For prevention of vomiting due to motion sickness in dogs 4 months and older, the tablets should be administered orally at a minimum dose of 8 mg/kg (3.6 mg/lb) once daily for up to two days.
The product labeling warns that people handling, administering, or exposed to maropitant citrate tablets may have allergic skin reactions if the product gets on their skin. People administering the product are advised to wash their hands with soap and water afterward.
Generic maropitant citrate tablets are sponsored ZyVet Animal Health Inc., based in Pennington, New Jersey.
The FDA approved Tauramox (PDF), a generic moxidectin injectable solution for the treatment and control of internal and external parasites in beef and nonlactating dairy cattle.
Tauramox is an antiparasitic drug that contains the same active ingredient, moxidectin, in the same concentration and dosage form as the approved brand-name drug product, Cydectin. Cydectin was first approved for use in in beef and nonlactating dairy cattle in 2005.
Tauramox comes in 250- and 500-mL bottles, each containing moxidectin at a concentration of 10 mg/mL. Both bottles are available over the counter.
Tauramox is administered as a single subcutaneous injection at a dose of 1 mL/50 kg (1 mL/110 lb) or 0.2 mg/kg (0.09 mg/lb). The withdrawal period established for this dosage of moxidectin is 21 days.
When administered as labeled, Tauramox is effective for the treatment and control of certain gastrointestinal roundworms, lungworms, cattle grubs, mites, and lice.
Tauramox is sponsored by Norbrook Laboratories Ltd. of Northern Ireland.
The FDA approved RESPIRmycin 25 (PDF), a generic tulathromycin injection solution for use in swine, suckling calves, dairy calves, and veal calves.
Specifically, RESPIRmycin 25 injectable solution is indicated for the treatment of swine respiratory disease associated with Actinobacillus pleuropneumoniae,
Pasteurella multocida, Bordetella bronchiseptica, Haemophilus parasuis, and
Mycoplasma hyopneumoniae. It is also indicated for the control of SRD associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, and Mycoplasma hyopneumoniae in groups of pigs where SRD has been diagnosed.
In addition, the product is indicated for the treatment of bovine respiratory disease associated with Mannheimia haemolytica, Pasteurella multocida, Histophilus somni, and Mycoplasma bovis.
RESPIRmycin 25 is an antimicrobial that contains the same active ingredient, tulathromycin, in the same concentration and dosage form as the approved brand-name drug product, Draxxin. Draxxin was first approved for use in swine in 2013, and in suckling calves, dairy calves, and veal calves in 2014.
RESPIRmycin 25 is supplied in 100-mL vials containing a tulathromycin concentration of 25 mg/mL. It is available by prescription from a licensed veterinarian.
In calves, the product is administered as a single subcutaneous injection in the neck at a dose of 1 mL/10 kg (1 mL/22 lb) or 2.5 mg/kg (1.1 mg/lb). The withdrawal period established for tulathromycin in suckling calves, dairy calves, and veal calves is 22 days.
In swine, the product is administered as an intramuscular injection in the neck, also at a dose of 1 mL/10 kg. The withdrawal period established for tulathromycin in swine is five days.
RESPIRmycin 25 is sponsored by Parnell Technologies, based in New South Wales, Australia.