Drugs for treating heart failure, respiratory diseases receive FDA approval

The first generic torsemide oral solution for pulmonary edema in dogs is among the approvals

The Food and Drug Administration (FDA) announced in April and May that it approved several animal drugs, including those that treat congestive heart failure in dogs and respiratory diseases in cattle and swine.

Torsemide for dogs

The FDA conditionally approved UpCard-CA1, the first torsemide oral solution for the management of pulmonary edema in dogs with congestive heart failure caused by myxomatous mitral valve disease (MMVD).

The drug is to be used concurrently with pimobendan, spironolactone, and an angiotensin-converting enzyme inhibitor.

Congestive heart failure caused by MMVD is a serious and life-threatening disease in dogs if left untreated. For this reason, the FDA determined that UpCard-CA1 met the eligibility criteria for expanded conditional approval.

A bottle of UpCard-CA1 with a syringe laying in front
The Food and Drug Administration conditionally approved UpCard-CA1 for the management of pulmonary edema in dogs with congestive heart failure caused by myxomatous mitral valve disease. (Courtesy of Vetoquinol USA Inc.)

The initial conditional approval is valid for one year with the potential for four annual renewals. During this time, the animal drug sponsor must demonstrate that it is actively working toward collecting the remaining effectiveness data needed for full approval.

UpCard-CA1 is available in 32- or 96-mL vials and is given orally once daily at a dose of 0.11 to 0.44 mg/kg (0.05 to 0.2 mg/lb) of bodyweight.

UpCard-CA1 is sponsored by Vetoquinol USA Inc., based in Fort Worth, Texas.

Pimomedin for dogs

The FDA approved Pimomedin, a generic pimobendan chewable tablet for managing the signs of congestive heart failure in dogs due to clinical MMVD or dilated cardiomyopathy (DCM).

Pimomedin is indicated for use with concurrent therapy for congestive heart failure, such as furosemide, as determined on a case-by-case basis.

The drug contains the same active ingredient, pimobendane, in the same concentration and dosage form as the approved brand name drug product, Vetmedin, which was first approved on April 30, 2007.

Pimomedin is available by prescription from a licensed veterinarian and comes in 1.25, 2.5, 5, and 10 mg oblong half-scored chewable tablets with 50 tablets per bottle. Pimomedin is administered orally at a total daily dose of 0.5 mg/kg (0.23 mg/lb) of body weight.

Pimomedin is sponsored by Cronus Pharma Specialities India Private Ltd., based in India.

Pradalex for cattle, swine

The FDA approved Pradalex, a pradofloxacin injection solution for treating certain respiratory diseases in cattle and swine.

Pradalex is a third-generation fluoroquinolone administered as a single injection. Pradofloxacin is a critically important antimicrobial that may only be prescribed by a licensed veterinarian.

Since 1997, the FDA has prohibited the extralabel use of fluoroquinolones in food-producing animals for purposes other than those approved by the agency.

Pradalex is approved in certain ages and classes of cattle for the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, Histophilus somni, and Mycoplasma bovis.

The drug can only be prescribed for cattle intended for slaughter and cattle intended for breeding that are less than 1 year of age.

The FDA also approved Pradalex for use in swine for the treatment of swine respiratory disease (SRD) associated with Bordetella bronchiseptica, Glaesserella (Haemophilus) parasuis, Pasteurella multocida, Streptococcus suis, and Mycoplasma hyopneumoniae.

It can only be prescribed for weaned swine intended for slaughter, not for breeding or nursing piglets.

Elanco conducted multi-site field studies to demonstrate the safety and efficacy of Pradalex for treating BRD in cattle and SRD in swine. The FDA also assessed the safety of edible products from cattle and swine treated with Pradalex.

Pradalex is supplied in 100- and 250-mL bottles, with each mL containing 200 mg of pradofloxacin. The drug is administered as a single subcutaneous injection in cattle at a dosage of 10 mg/kg (4.54 mg/lb) of body weight and by intramuscular injection in swine at 7.5 mg/kg (3.4 mg/lb) of body weight.

Pradalex is sponsored by Elanco, based in Greenfield, Indiana.

Visit the Food and Drug Administration’s website to see a full list of recent animal drug approvals.