FDA Approves First Generic Tulathromycin Products for Treating Disease in Certain Cattle and Swine

 

Source: FDA Center for Veterinary Medicine

February 19, 2021

 

The FDA has approved the first two generic tulathromycin injectable products for the treatment and control of certain diseases in both cattle and swine. Both generic products, Macrosyn and Increxxa, are approved for the following indications:

 

?span style='font:7.0pt "Times New Roman"'>         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;

?span style='font:7.0pt "Times New Roman"'>         control of respiratory disease in beef and non-lactating dairy cattle at high risk of developing BRD associated with Mannheimia haemolytica, Pasteurella multocida, Histophilus somni, and Mycoplasma bovis;

?span style='font:7.0pt "Times New Roman"'>         treatment of infectious bovine keratoconjunctivitis (IBK) associated with Moraxella bovis in beef and non-lactating dairy cattle;

?span style='font:7.0pt "Times New Roman"'>         treatment of bovine foot rot (interdigital necrobacillosis) associated with Fusobacterium necrophorum and Porphyromonas levii in beef and non-lactating dairy cattle;

?span style='font:7.0pt "Times New Roman"'>         treatment of swine respiratory disease (SRD) associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, Bordetella bronchiseptica, Haemophilus parasuis, and Mycoplasma hyopneumoniae in pigs; and?

?span style='font:7.0pt "Times New Roman"'>         control of SRD associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, and Mycoplasma hyopneumoniae in groups of pigs where SRD has been diagnosed.

 

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 of the active ingredient.

 

more, including links

https://www.fda.gov/animal-veterinary/cvm-updates/fda-approves-first-generic-tulathromycin-products-treating-disease-certain-cattle-and-swine

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

在线看日本免费不卡资源_在线不卡日本v二区三区18_xxxx日本