Feds approve drugs for treating bovine respiratory disease, skin infections

Several animal drugs have come to market in past months, including a new vaccine to protect dogs against kennel cough, generic sedatives, and drugs to treat bovine respiratory disease and skin infections in dogs and cats.

Vanguard Recombishield for dogs

On November 10, Zoetis announced the launch of Vanguard Recombishield, a new injectable vaccine to protect dogs 8 weeks and older against one of the pathogens that causes kennel cough (Bordetella bronchiseptica).

The U.S. Department of Agriculture (USDA) licensed the vaccine in March, which uses recombinant technology, according to a company press release calling Recombishield the first and only canine vaccine "with pertactin protein for an optimized immune response."

Several animal drugs have come to market in past months, including a new vaccine to protect dogs against kennel cough and drugs to treat bovine respiratory disease, skin infections in dogs and cats, and more.

Zoetis says the nonadjuvanted vaccine also helps minimize discomfort and vocalization during administration, as well as pain, swelling, and reactivity.

"Every dog is different, and intranasal or oral delivery may not be the right fit for every dog to protect against kennel cough," said Dr. Tara Bidgood, vice president and head of U.S. veterinary professional services and medical affairs for Zoetis Petcare. "However, given how quickly Bordetella can spread, it is important to ensure dogs are fully protected from this potentially serious bacterial infection … regardless of their specific needs or temperament."

The new vaccine is intended to replace Zoetis' Vanguard B Injectable, the previous Vanguard injectable product in its suite of Bordetella vaccines. However, veterinarians may continue to use their remaining inventory.

Available in 1 mL vials, the injectable vaccine can be administered subcutaneously. Healthy dogs should receive two doses, three to four weeks apart.

Pennitracin and Monteban for chicken feed

The U.S. Food and Drug Administration (FDA) on October 21 granted approval for the combination use of antimicrobial Pennitracin MD 50G (bacitracin Type A medicated article) and anticoccidial Monteban (narasin Type A medicated article) in Type C medicated feeds for use in broiler chickens.

The Food and Drug Administration has approved the combination use of Pennitracin MD 50G and Monteban in broiler feed. This dual-action additive is indicated to control coccidiosis and necrotic enteritis while improving weight gain and feed efficiency.

Elanco Animal Health granted Pharmgate Inc. permission to use data from its existing drug approval in order to use Monteban in this combination. Monteban is an ionophore that protects intestinal integrity by controlling coccidia and bacterial enteritis while maintaining feed intake.

This animal feed additive combination is indicated for increased rate of weight gain and improved feed efficiency, as well as for the prevention of coccidiosis caused by Eimeria necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, and E. maxima. It is also approved for the prevention of mortality caused by necrotic enteritis associated with Clostridium perfringens.

Available over the counter, Pennitracin MD 50G comes in a 50-lb bag and Monteban comes in a 55.12-lb bag.

The dosage regimens vary. For increased rate of weight gain and improved feed efficiency, as well as for the prevention of coccidiosis in broiler chickens, it is 4 to 50 grams per ton of bacitracin (as feed grade bacitracin methylenedisalicylate) and 54 to 90 grams per ton of narasin. The combination should be fed as the sole ration throughout the feeding period. The concentration of narasin should be adjusted according to the severity of the coccidial challenge.

For the prevention of mortality caused by necrotic enteritis and for the prevention of coccidiosis in broiler chickens, the dosage regimen is 50 grams per ton of bacitracin and 54 to 90 grams per ton of narasin. The combination should be fed as the sole ration for 28 to 35 days, from the time chicks are placed for brooding, and the narasin concentration adjusted according to the severity of the coccidial challenge.

The combination use of Pennitracin MD 50G and Monteban has a zero-day withdrawal period.

Gamrozyne for cattle

The FDA on August 28 approved Gamrozyne, an injectable gamithromycin solution for beef and nonlactating dairy cattle. The antimicrobial is indicated for treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, Histophilus somni, and Mycoplasma bovis.

Gamrozyne is available by prescription from a licensed veterinarian and is supplied in 100 mL, 250 mL, and 500 mL multidose vials with 150 mg of gamithromycin per mL.

It is administered as a subcutaneous injection in the neck at a dose of 6 mg per kg (2 mL/110 lb) of body weight. No more than 10 mL should be administered at each injection site.

A withdrawal period of 35 days has been established for gamithromycin in beef and non-lactating dairy cattle.

Gamrozyne is sponsored by Bimeda Animal Health and the first FDA-approved generic version of the approved brand name drug product, Zactran, which is manufactured by Boehringer Ingelheim Animal Health and was first approved in 2011.

MGA, Experior, Monovet, and Tylovet

The FDA in July approved the combination of MGA (melengestrol acetate), Experior (lubabegron), Monovet (monensin), and Tylovet (tylosin phosphate) in beef cattle feeds for increased rate of weight gain, improved feed efficiency, and suppression of estrus, among other indications.

A new FDA-approved medicated feed for growing heifers combines a steroid (MGA), a beta-agonist (Experior), an ionophore (Monovet), and an antimicrobial (Tylovet). Benefits include increased weight gain, estrus suppression, and coccidiosis control.

The Type A medicated articles are to be used in the manufacture of Type C medicated feeds for growing heifers fed in confinement for slaughter.

A steroid hormone, MGA comes in two varieties: MGA 200 comes in a 50-lb bag with 200 mg of melengestrol acetate per lb, while MGE 500 comes in a 40-lb liquid formulation with 500 mg of melengestro acetate per lb.

Experior, a beta-adrenergic agonist/antagonist, is supplied in a 10 kg bag at either 10 grams per kg (4.54 g/lb) and 50 grams per kg (22.7 g/lb) of lubabegron fumarate.

Monovet, an ionophore, is supplied in a 55.12-lb bag with 90.7 grams per lb of monesin, and Tylovet, an antimicrobial, is supplied in a 50-lb bag at either 40 grams per lb or 100 grams per lb of tylosin.

For increased rate of weight gain, improved feed efficiency, suppression of estrus, reduction of ammonia gas emissions per pound of live weight and hot carcass weight, and the prevention and control of coccidiosis caused by Eimeria bovis and Eimeria zuernii, beef cattle should be on this combination during the last 14 to 91 days on feed. The dosage regimen varies and a veterinary feed directive is required.

The withdrawal period for the generic combination is zero days.

The FDA previously approved the combination of Experior, Monovet, and Tylovet in 2022. Huvepharma sponsored both combinations of Type A medicated articles to be used in the manufacture of Type C medicated feeds.

Antimicrobial tablets

Felix Pharmaceuticals, a manufacturer of generic companion animal drugs based in Ireland, had two new animal drug submissions approved by the FDA this summer. The first was Cefpodoxime Proxetil Tablets for the treatment of skin infections in dogs.

Specifically, the antimicrobial is indicated for the treatment of skin infections, such as wounds and abscesses, caused by susceptible strains of Staphylococcus pseudintermedius, Staphylococcus aureus, Streptococcus canis, Escherichia coli, Pasteurella multocida, and Proteus mirabilis

Cefpodoxime Proxetil Tablets come in 100-count and 250-count bottles for each tablet strength. They are only available by prescription from a licensed veterinarian. The dose range is 5-10 mg per kg (2.3-4.5 mg/lb) body weight. It should be administered orally once a day for five to seven days or for two to three days after clinical signs cease, for up to 28 days.

The 100 mg Cefpodoxime Proxetil Tablet is bioequivalent to the 100 mg Simplicef tablet, which is the approved brand name drug product that is sponsored by Zoetis and was first approved in 2004.

In addition, the agency approved Felix's Clindamycin Hydrochloride Tablets for the treatment of infections caused by susceptible strains of designated microorganism in dogs.

Specifically, the antimicrobial is indicated for wounds and abscesses due to coagulase positive staphylococci (Staphylococcus aureus or Staphylococcus intermedius) along with dental infections and osteomyelitis due to S aureus, Bacteroides fragilis, Prevotella melaninogenicus, Fusobacterium necrophorum, and Clostridium perfringens.

Clindamycin Hydrochloride Tablets are supplied in 400-, 200-, and 100-tablet bottles with 25 mg, 75 mg, and 150 mg of clindamycin hydrochloride per tablet, respectively.

The tablets are available by prescription only from a licensed veterinarian and administered orally. To treat infected wounds, abscesses, and dental infections in dogs, the recommended dose is 2.5-15.0 mg per lb body weight every 12 hours. Treatment with Clindamycin Hydrochloride Tablets may be continued up to a maximum of 28 days.

For osteomyelitis, the recommended dose is 5.0-15.0 mg per lb body weight every 12 hours. Treatment is recommended for a minimum of 28 days, but should not be continued any longer if no response to therapy is seen

The 150 mg Clindamycin Hydrochloride Tablet is bioequivalent to the 150 mg Antirobe capsule, which is the approved brand name drug product that is sponsored by Zoetis.

Dexmedetomidine hydrochloride

More recently, the FDA approved on September 19 Felix's Dexmedetomidine Hydrochloride for use in dogs and cats.

Specifically, the alpha2-adrenoreceptor agonist is indicated for use as a sedative and analgesic in dogs and cats to help facilitate clinical examinations, clinical procedures, and minor surgical and dental procedures. The injectable solution is also indicated for use as a preanesthetic to general anesthesia.

Available by prescription only from a licensed veterinarian, the sterile injectable solution is supplied in 10 mL multidose vials containing 0.5 mg of dexmedetomidine hydrochloride per mL. The dosing regimen varies by animal.

Dexmedetomidine Hydrochloride contains the same active ingredient, cefovecin sodium, as the approved brand name drug product, Dexdomitor, which is sponsored by Orion Corp., and was approved for use in dogs in 2006 and in cats in 2007 as a sedative and analgesic, and in 2010 as a preanesthetic.