FDA approves generic therapy for bovine respiratory disease

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Officials with the FDA have approved a generic gamithromycin injectable solution for the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, Histophilus somni and Mycoplasma bovis in beef and nonlactating dairy cattle. The newly approved product (Gamrozyne; Bimedia Animal Health) is the first generic version of Boehringer Ingelheim’s pioneer product Zactran and is bioequivalent.¹

Gamrozyne is also indicated for the control of respiratory disease in beef and non-lactating dairy cattle at high risk of developing BRD associated with Mannheimia haemolytica and Pasteurella multocida, according to the FDA. The generic therapy is available only by prescription from a licensed veterinarian.¹

BRD is a complex condition, according to Texas A&M University College of Veterinary Medicine & Biomedical Sciences. It is a leading cause of death in cattle and can affect any breed and age of these ungulates.²

An early sign of BRD in cattle is lagging behind their group or self-isolation. Additional clinical signs may include fever greater than 104^o F, eye and nose discharge, coughing, and a tilted head or ear position. Signs of depression such as decreased appetite, slow body movement, and an unwillingness to stand, can also be clinical signs of BRD, according to Texas A&M.²

The risk of BRD can be lowered by reducing stress, according to Texas A&M. Proper ventilation, minimal pen movements, use of low-stress handling techniques, clean bedding and proper access to food and water are among the actions that can help reduce stress.²

In treating BRD, Gamrozyne is administered to beef and nonlactating dairy cattle through a subcutaneous injection in the neck at rate of 6 mg/kg (2 mL/110 lb) body weight. If the total dose exceeds 10 mL, divide the dose so that no more than 10 mL is administered at each injection site.¹

Reference

1. FDA approves first generic gamithromycin injectable for treatment and control of bovine respiratory disease in beef and non-lactating dairy cattle. News release. FDA. August 28, 2025. Accessed August 28, 2025. https://content.govdelivery.com/accounts/USFDA/bulletins/3edbe06
2. Pet Talk. The cattle battle: bovine respiratory disease. Texas A&M University College of Veterinary Medicine & Biomedical Sciences. June 30, 2022. Accessed August 28, 2025. http://vetmed.tamu.edu/news/pet-talk/bovine-respiratory-disease/