FDA has approved the first generic tulathromycin products for treating disease in certain cattle and swine. The patent on Draxxin is expired and generics will be hitting the market shortly. Zoetis has dropped the price and is also rolling out a version of Draxxin that includes ketoprofen, an NSAID.
What is Draxxin injectable solution?
DESCRIPTION: Draxxin® Injectable Solution is a ready-to-use sterile parenteral preparation containing tulathromycin, a semi-synthetic macrolide antibiotic of the subclass triamilide.
Is Draxxin legal in the US?
Federal (USA) law restricts this drug to use by or on the order of a licensed veterinarian. DRAXXIN Injectable Solution is a ready-to-use sterile parenteral preparation containing tulathromycin, a semi-synthetic macrolide antibiotic of the subclass triamilide.
What is Draxxin used for in cattle?
PARSIPPANY, N.J., Aug. 9, 2021 — Zoetis today announced a new combination product to treat bovine respiratory disease (BRD) and control related fever (pyrexia): Draxxin ® KP ( tulathromycin and ketoprofen injection) Injectable Solution. It’s a new single-treatment option for beef and dairy producers.
What is Draxxin Tulathromycin?
DRAXXIN tulathromycin, is the first entry of a novel macrolide subclass, the triamilides, developed by Pfizer Animal Health. DRAXXIN is now the first-line product-of-choice to treat BRD, offering both superior disease treatment as well as outstanding efficacy for the control of BRD in cattle at high risk of developing the disease.
Is Macrosyn the same as Draxxin?
In gaining approval from the U.S. Food and Drug Administration (FDA), Macrosyn ™ was granted the same label claims as Draxxin ® and is bioequivalent to the pioneer product in: Active ingredient & inactive ingredients (including carriers and excipients) Strength, dosage form & route of administration.
Is Increxxa the same as Draxxin?
Macrosyn and Increxxa contain the same active ingredient (tulathromycin) in the same concentration and dosage form as the approved brand name drug product, Draxxin, which was first approved in 2005.
How much does Draxxin cost?
Draxxin Injectable Antibiotic for Swine and CattleSKUProduct NamePrice4851Draxxin (50 mL)$223.354834Draxxin (100 mL)$413.594835Draxxin (250 mL)$983.168186Draxxin (500 mL)$1,867.58
What is the difference between Nuflor and Draxxin?
DRAXXIN was significantly more effective, in 2 studies with feeder cattle, than was Nuflor® (florfenicol) Injectable Solution. First-treatment success, in both studies, for days 3 to 28 was significantly higher (P≤0.001, P=0.002) for cattle treated with DRAXXIN than for those treated with Nuflor.
Is Zactran the same as DRAXXIN?
ZACTRAN was superior to DRAXXIN for control of BRD, and BRD with co-morbidity by otitis media (Table 1 and Figure 1). Both antimicrobials were superior to no medication (no metaphylaxis), requiring fewer treatments for BRD and/or otitis media. Mortality was not different among the treatment groups.
What is the difference between Nuflor and Resflor?
What else is different? The Resflor Gold® product contains the anti-inflammatory compound flunixin, while the Nuflor Gold® does not.
Is Draxxin over the counter?
Have you ever wondered why those antibiotics are readily available for anyone while newer drugs like Draxxin or Zuprevo aren't? Penicillin, sulfa, and tetracyclines are “over the counter” antibiotics, in contrast to “prescription” drugs.
How much is a 500ml bottle of Draxxin?
Draxxin Injectable SolutionCatalog #DescriptionPricesc-395503Rx50 ml$218.88sc-362921Rx100 mg/ml, 100 ml$405.32sc-362922Rx100 mg/ml, 250 ml$963.50sc-362923Rx100 mg/ml, 500 ml$2,078.95
How often can you inject Draxxin?
Inject subcutaneously as a single dose in the neck at a dosage of 2.5 mg tulathromycin and 3 mg ketoprofen/kg (1.1 mL/100 lb) bodyweight (BW). Do not inject more than 10 mL per injection site. Use this product within 56 days of the first puncture and puncture a maximum of 20 times.
Is Zuprevo the same as Draxxin?
Draxxin® provided substantial health and economic benefits compared to Zuprevo™ for controlling the negative impacts of BRD in highrisk stocker calves. For use in beef cattle (including suckling calves), non-lactating dairy cattle (including dairy calves) and veal calves.
What is the best antibiotic for cattle?
The tetracyclines have been the most widely used antibiotics in the beef cattle industry. (Recently monensin has been approved for use for improved feed efficiency in feedlot cattle. General use by the industry has been rapid. Only tylosin in combination with monensin has been approved for use at this time.)
How long is Draxxin effective in cattle?
IMPORTANT SAFETY INFORMATION FOR DRAXXIN: Draxxin has a pre-slaughter withdrawal time of 18 days in cattle. Do not use in female dairy cattle 20 months of age or older.
What is Draxxin used for?
Foot Rot – DRAXXIN Injectable Solution is indicated for the treatment of bovine foot rot (interdigital necrobacillosis) associated with Fusobacterium necrophorum and Porphyromonas levii.
What is a dracxin injection?
DRAXXIN Injectable Solution is a ready-to-use sterile parenteral preparation containing tulathromycin, a semi-synthetic macrolide antibiotic of the subclass triamilide. Each mL of DRAXXIN contains 100 mg of tulathromycin as the free base in a 50% propylene glycol vehicle, monothioglycerol (5 mg/mL), with citric and hydrochloric acids added to adjust pH.
How effective is Draxxin for foot rot?
Foot Rot - The effectiveness of DRAXXIN for the treatment of bovine foot rot was evaluated in 170 cattle in two field studies. Cattle diagnosed with bovine foot rot were enrolled and treated with a single subcutaneous dose of DRAXXIN (2.5 mg/kg BW) or an equivalent volume of saline. Cattle were clinically evaluated 7 days after treatment for treatment success, which was based on defined decreases in lesion, swelling, and lameness scores. In both studies, the treatment success percentage was statistically significantly higher in DRAXXIN-treated calves compared with saline-treated calves (60% vs. 8%, P < 0.0001 and 83.3% vs. 50%, P = 0.0088).
What is the ratio of dracxin to tulathromycin?
DRAXXIN consists of an equilibrated mixture of two isomeric forms of tulathromycin in a 9:1 ratio. Structures of the isomers are shown below.
How many pigs were treated with Draxxin?
In a multi-location field study to evaluate the treatment of naturally occurring SRD, 266 pigs were treated with DRAXXIN. Responses to treatment were compared to saline-treated controls. Success was defined as a pig with normal attitude, normal respiration, and rectal temperature of < 104°F on Day 7. The treatment success rate was significantly greater (P ≤ 0.05) in DRAXXIN-treated pigs (70.5%) compared to saline-treated pigs (46.1%). M. hyopneumoniae was isolated from 106 saline-treated and non-treated sentinel pigs in this study.
Is draxxin a contraindication?
The use of DRAXXIN Injectable Solution is contraindicated in animals previously found to be hypersensitive to the drug.
Does draxxin affect porcine reproductive performance?
Swine. The effects of DRAXXIN on porcine reproductive performance, pregnancy, and lactation have not been determined. Intramuscular injection can cause a transient local tissue reaction that may result in trim loss of edible tissue at slaughter.
What is BRD treatment?
treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, Histophilus somni, and Mycoplasma bovis in beef and non-lactating dairy cattle, suckling calves, dairy calves and veal calves;
Is Increxxa safe for cattle?
The data submitted in support of these Abbreviated New Animal Drug Applications demonstrate that Macrosyn and Increxxa, when used according to their labels, are safe and effective. Additionally, the data demonstrate that residues in food products derived from beef cattle, non-lactating dairy cattle, suckling calves, dairy calves, veal calves and swine treated with Macrosyn and Increxxa do not present a public health concern when the products are used according to their labels.
Is Draxxin available by prescription?
Accordingly, like Draxxin, Macrosyn and Increxxa are only available by prescription because a veterinarian’s expertise is required to determine whether tulathromycin is an appropriate therapy and to help guide its judicious use to slow the development of antimicrobial resistance.
Is Increxxa the same as Macrosyn?
Macrosyn and Increxxa contain the same active ingredient (tulathromycin) in the same concentration and dosage form as the approved brand name drug product, Draxxin, which was first approved in 2005. In addition, the FDA determined that Macrosyn and Increxxa contain no inactive ingredients that may significantly affect the bioavailability ...
Is tulathromycin a generic?
Additionally, tulathromycin is only approved for use as a single dose. The FDA does not expect that these approvals will increase the overall use of tulathromycin; instead, these generic approvals provide veterinarians with options when prescribing a tulathromycin product.
What is a draxxin?
DESCRIPTION: Draxxin® Injectable Solution is a ready-to-use sterile parenteral preparation containing tulathromycin, a semi-synthetic macrolide antibiotic of the subclass triamilide. Each mL of Draxxin Injectable Solution contains 100 mg of tulathromycin as the free base in a propylene glycol vehicle.
What is draxxin injection?
Bovine respiratory disease (BRD): Draxxin Injectable Solution is indicated for the treatment of BRD associated with Mannheimia haemolytica, Pasteurella multocida, Histophilus somni (Haemophilus somnus) and Mycoplasma bovis and for the reduction of morbidity associated with BRD in feedlot calves caused by Mannheimia haemolytica, Pasteurella multocida, Histophilus somni and Mycoplasma bovis, during the first 14 days in the feedlot when administered at the time of arrival .
When should Draxxin be used?
Note: To limit the development of antimicrobial resistance, Draxxin Injectable Solution should only be used for control of SRD when segregation and treatment of individual sick animals is unlikely to control the disease outbreak.
Can Draxxin be used as an arrival treatment?
Note: To limit the development of antimicrobial resistance, Draxxin Injectable Solution should only be used as an arrival treatment when: 1) BRD has been diagnosed and 2) calves are at “high risk” of developing BRD. One or more of the following factors typically characterizes calves at “high risk” of developing BRD.
Is Draxxininjectable Solution contraindicated?
DraxxinInjectable Solution is contraindicated in animals previously found to be hypersensitive to macrolide antibiotics.
Can Draxxin be given to sheep?
The safety of Draxxin Injectable Solution has not been demonstrated in pigs less than 4 weeks of age or in sheep less than 6 weeks of age.
What are the side effects of Draxxin?
In one field use study two calves exhibited hypersalivation and one of these calves also experienced difficulty breathing ( dyspnea), which may have been associated with pneumonia.
Is Draxxin a first line product?
DRA XXIN is now the first-line product-of-choice to treat BRD, offering both superior disease treatment as well as outstanding efficacy for the control of BRD in cattle at high risk of developing the disease.
What does KP stand for in draxxin?
As if there isn’t enough choice already, the company that makes Draxxin has also released Draxxin KP. The KP stands for ketoprofen, an anti-inflammatory drug. This would provide a combination product with an NSAID (non-steroidal anti-inflammatory drug) to help control inflammation and reduce fever in pneumonia. This product is only listed with U.S. availability but I am sure they are licensing it in Canada.
What are the names of the new generics?
The new generic products will have names like Lydaxx, Tulamaxx, Tulaven, Tulisson and Increxxa. Naming relates to the active ingredient or the original product, Draxxin, with the double x.
Do Draxxin macrolides come in plastic bottles?
I believe two of the new Draxxin-like macrolides come in plastic bottles. This is a great trend in the cattle industry to decrease breakage during shipping but also when administering it chute side or packing it in a treatment kit.
Is Draxxin patent off?
Now that the patent is off Draxxin, several companies have manufactured products with the same active molecule. However, producers should follow the lead of their herd veterinarian before making any changes to prevention or treatment of feedlot cattle.
Do all veterinary products need a prescription?
All these products need a veterinary prescription so the veterinary-client-patient relationship is vital.
Is Draxxin safe for cows?
Draxxin has also been used to treat foot rot and pinkeye in the cow-calf sector and those indications are on the label. Use in dart guns has increased, but I hope this only occurs upon clear advice from a veterinarian. It is a Class 2 antimicrobial so it should only be used when needed and when there is no alternative that would be as effective.
How long does it take for Draxxin to be withdrawn from cattle?
IMPORTANT SAFETY INFORMATION FOR DRAXXIN KP: Draxxin KP has a pre-slaughter withdrawal time of 18 days in cattle. Not for use in female dairy cattle 1 year of age or older, including dry dairy cows. Not for use in beef calves less than 2 months of age, dairy calves, and veal calves. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in animals previously found to be hypersensitive to tulathromycin and ketoprofen. See full Prescribing Information.
Is Draxxin KP a fast acting drug?
Draxxin KP includes the well-known effectiveness of Draxxin ® ( tulathromycin injection) Injectable Solution and adds ketoprofen, a fast-acting nonsteroidal anti-inflammatory drug (NSAID), in a single treatment approved for use in beef steers, beef heifers, beef calves two months of age and older, beef bulls, dairy bulls and dairy replacement heifers.
What is the FDA approved name for dexilant?
Dexilant is a brand name of dexlansoprazole, approved by the FDA in the following formulation (s):
What is a reference listed drug?
A Reference Listed Drug (RLD) is an approved drug product to which new generic versions are compared to show that they are bioequivalent. A drug company seeking approval to market a generic equivalent must refer to the Reference Listed Drug in its Abbreviated New Drug Application (ANDA). By designating a single reference listed drug as the standard to which all generic versions must be shown to be bioequivalent, FDA hopes to avoid possible significant variations among generic drugs and their brand name counterpart.
How long does a drug patent last?
The patent assigns exclusive legal right to the inventor or patent holder, and may include entities such as the drug brand name, trademark, product dosage form, ingredient formulation, or manufacturing process A patent usually expires 20 years from the date of filing, but can be variable based on many factors, including development of new formulations of the original chemical, and patent infringement litigation.
Is Dexilant 60 mg counterfeit?
Strength (s): 60MG [ AB ] Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Dexilant. These medications may be counterfeit and potentially unsafe. If you purchase medications online, be sure you are buying from a reputable and valid online pharmacy.
Has a generic version of Dexilant been approved?
A generic version of Dexilant has been approved by the FDA. However, this does not mean that the product will necessarily be commercially available - possibly because of drug patents and/or drug exclusivity. The following products are equivalent to Dexilant and have been approved by the FDA:
Draxxin Injectable Solution Indications
Dosage and Administration
- Cattle:Inject subcutaneously in the neck, a single dose of 2.5 mg/kg body weight (1.25 mL/50 kg). Care should be taken to dose accurately. Do not inject more than 10 mL per injection site. Most animals will respond to treatment within 3 to 5 days. If no improvement is observed, the diagnosis should be re-evaluated. On Arrival Treatment: Note: To limit the development of antimicrobial re…
Contraindications
- DraxxinInjectable Solution is contraindicated in animals previously found to be hypersensitive to macrolide antibiotics. CAUTIONS: The effects of Draxxin Injectable Solution on bovine, ovine and porcine reproductive performance, pregnancy and lactation have not been determined. Subcutaneous injection in cattle and intramuscular injection in swine can cause a local tissue re…
Clinical Pharmacology
- Although the relationship between tulathromycin and the characteristics of its antimicrobial effects has not been characterized, as a class, macrolides tend to be primarily bacteriostatic, but may be bactericidal against some pathogens2. They also tend to exhibit concentration independent killing; the rate of bacterial eradication does not change once serum drug concentr…
Storage
- PRESENTATION: DraxxinInjectable Solution is available in 20 mL, 50 mL, 100 mL, 250 mL and 500 mL vials. Zoetis is a trademark and Draxxin is a registered trademark of Zoetis or its licensors, used under license by Zoetis Canada Inc. Zoetis Canada Inc., Kirkland QC H9H 4M7 8197-11-3a CPN:1198331.7