- First-of-its-kind treatment to be approved by FDA in more than a decade
- Pradalex now available to treat bovine and swine respiratory diseases
GREENFIELD, Ind. (February 4, 2025) — Elanco Animal Health Incorporated announced today the availability of its latest innovation: Pradalex™ (pradofloxacin injection) for the treatment of bovine respiratory disease (BRD) and swine respiratory disease (SRD). Pradalex is the first new molecule and injectable antibiotic treatment to be approved by the U.S. Food and Drug Administration (FDA) to treat BRD and SRD in roughly two decades. In the cattle industry, BRD — or “shipping fever” — is one of the most frequent and costly stocker and feedlot diseasesi, affecting the health and wellbeing of animals and potentially costing producers $1 billion annually.ii Similarly, SRD is the most prevalent cause of nursery and grow-finish pig deaths in the U.S.iii, creating substantial production and economic losses for producersiv and accounting for additional annual costs of up to $5 per pig.v
“The launch of Pradalex further demonstrates Elanco’s commitment to bring new tools and innovations that help address some of our customers’ biggest challenges,” says Dr. José Manuel Correia de Simas, Executive Vice President, U.S. Farm Animal at Elanco. “Pradalex is a new molecule with a novel mode of action that treats respiratory diseases in beef and swine, strengthening our portfolio of solutions and providing veterinarians and producers with multiple choices to prevent and control respiratory challenges.”
Pradalex is a convenient single-dose, low-volume antibiotic with excellent syringeability and an industry-leading withdrawal period. Pradalex’s structural differences result in a dual targeting effect, yielding improved potency compared to similar antibiotics.vi Pradalex is indicated for the treatment of BRD and SRD and kills major BRD and SRD bacteria, including Mannheimia haemolytica, Pasteurella multocida, Histophilus somni and Mycoplasma bovis in cattle and Bordetella bronchiseptica, Pasteurella multocida, Mycoplasma hyopneumoniae, Glaesserella (Haemophilus) parasuis and Streptococcus suis in pigs.
Pradalex is rapidly absorbed and distributed at the injection site, reaching a high and effective therapeutic concentration in plasma within 45 minutes of administration to cattle and a high maximum therapeutic concentration in cattle lung pulmonary epithelial lining fluid within six hours. This aids in the fast in-vitro elimination of bacteria* vii and limits lung damage in both cattleviii and swineix. Its novel pharmacokinetic and pharmacodynamic profile reduces the time needed to select resistant bacteria, contributing to judicious antibiotic use.
“Pradalex combines a high plasma peak concentration reached very quickly with a unique mode of action, resulting in comprehensive coverage of Gram-positive and Gram-negative pathogens,” comments Dr. Pat Hoffmann, Elanco Swine Technical Consultant. “It makes an exceptional option for a spot treatment injectable intervention.”
Pradalex is indicated for the treatment of SRD in weaned swine intended for harvest. It is not for use in swine intended for breeding (boars intended for breeding, replacement gilts and sows intended for breeding) and in nursing piglets.
“At Elanco, we focus on bringing producers a broad portfolio of solutions to support their disease prevention efforts, starting with vaccines and feed additives that optimize the health outcomes of calves.,” says Dr. Ronald Tessman, Elanco beef technical consultant. “When antibiotics are necessary, Elanco has a full range to fit producers’ needs. Pradalex is our newest antibiotic and is truly different from any other product on the market, giving producers another valuable tool that can be used in an integrated approach to reducing losses due to BRD.”
Pradalex is indicated for the treatment of BRD in beef cattle (calves two months of age and over, steers, heifers and bulls intended for slaughter and replacement heifers and bulls intended for breeding and less than one year of age) and dairy cattle (replacement heifers and bulls less than one year of age). It is not for use in male and female cattle intended for breeding that are over one year of age, in calves under two months of age or in veal calves.
Pradalex is available in 100 mL and 250 mL volumes — see more at farmanimal.elanco.com/us/swine/product/pradalex and pradalexforcattle.com.
Pradalex joins a wide portfolio of swine respiratory solutions and immune support options, in addition to Elanco's range of preventive and treatment solutions to empower cattle producers and feedlot operators to treat and control BRD challenges in their herds.
Elanco believes all medically important (shared class) antibiotics use should be only for therapy under the oversight of a veterinarian. More details on Elanco’s antibiotic, welfare and sustainability policies can be found on http://www.elanco.com/healthy-purpose#responsible-use-of-antibiotics.
ABOUT ELANCO
Elanco Animal Health Incorporated (NYSE: ELAN) is a global leader in animal health dedicated to innovating and delivering products and services to prevent and treat disease in farm animals and pets, creating value for farmers, pet owners, veterinarians, stakeholders and society as a whole. With 70 years of animal health heritage, we are committed to breaking boundaries and going beyond to help our customers improve the health of animals in their care, while also making a meaningful impact on our local and global communities. At Elanco, we are driven by our vision of Food and Companionship Enriching Life and our Elanco Healthy Purpose™ sustainability pillars – all to advance the health of animals, people, the planet and our enterprise. Learn more at www.elanco.com.
References:
*Clinical relevance has not been determined.
Pradalex, Elanco and the diagonal bar logo are trademarks of Elanco or its affiliates. © 2025 Elanco or its affiliates. PM-US-25-0214 (2)
i. Chai J, Capik S, Kegley B, et al. Bovine respiratory microbiota of feedlot cattle and is association with disease. Vet Res 53, 4 (2022). https://doi.org/10.1186/s13567-021-01020-x
ii. Wileman et al., 2009. “Analysis of modern technologies commonly used in beef cattle production: Conventional beef production versus nonconventional production using meta-analysis.” J Anim Sci 87(10):3418-3426
iii. National Animal Health Monitoring System. Swine `95: Grower/Finisher. Part II. Reference of 1995 U.S. Grower/Finisher Health and Management Practices, p. 14–16. 1996. U.S. Department of Agriculture, Fort Collins, Colo.
iv. Neumann E, Ramirez A, Schwartz K. eds. Swine disease manual. 4th ed. AASV. 2009; 9.
v. Brockmeier S, Halbur P, Thacker E. Porcine respiratory disease complex. In: Polymicrobial diseases. Brogden K, Guthmiller J, eds. ASM Press, Washington, DC. 2002; Ch. 13.
vi. Blondeau, J.M.; Fitch, S.D. Comparative In Vitro Killing by Pradofloxacin in Comparison to Ceftiofur, Enrofloxacin, Florfenicol, Marbofloxacin, Tildipirosin, Tilmicosin and Tulathromycin against Bovine Respiratory Bacterial Pathogens. Microorganisms 2024, 12,996. h://doi.org/10.3390/microorganisms12050996
vii. Blondeau, J.M.; Fitch, S.D. Comparative In Vitro Killing by Pradofloxacin in Comparison to Ceftiofur, Enrofloxacin, Florfenicol, Marbofloxacin, Tildipirosin, Tilmicosin and Tulathromycin against Bovine Respiratory Bacterial Pathogens. Microorganisms 2024, 12,996. h://doi.org/10.3390/microorganisms12050996
viii. Foster DM, Halleran JL, Jacob ME, et al. Pharmacokinetics of pradofloxacin, florfenicol, and tulathromycin and response to treatment of steers experimentally infected with Mannheimia hemolytica. J Vet Intern Med. 2025;39(1):e17270. doi:10.1111/jvim.17270
ix. Elanco Data on File
