The North Carolina-headquartered company announced on Tuesday [June 18] that the US Food and Drug Administration (FDA) had approved a new use of its generic antibiotic chlortetracycline product, Deracin.
A global producer of tetracyclines for use with livestock, Pharmgate has four research facilities around the world. The company also focuses on vaccine development and production.
The approval allows the chlortetracycline feed additive to be used in combination with the medication, tiamulin hydrogen fumarate, in swine feed, Denegard, said Ralph Wilson, veterinarian, Pharmgate Animal Health.
The new usage makes the medicated additive more competitive in the market and improves its efficacy, he told FeedNavigator.
“At any time, we’re trying to help an animal get well. It is plain intelligent that we do something that’s efficacious and something that acts quickly so we don’t have to prolong the treatment,” he said. “It’s not that tiamulin or chlortetracycline (CTC) couldn’t get the job done, but the combination is more efficacious and gets the job done more quickly.”
“Combinations are hard for the bacteria to deal with – [antibiotic] resistance is part of it and some of the bacteria have the ability to fend off the single approach, but when you give them a double whammy they can’t stand it,” Wilson said.
The CTC acts to slow down the development of harmful bacteria to allow an animal’s immune system to act, he added.
The company previously had approvals for the chlortetracycline medication to be used in Canada and Latin America, but it only recently applied to have the product approved for use in the US, he said.
In-feed use and competition
The drug combination is intended to be used to address swine dysentery, enteritis and pneumonia, the company reported. The blend of medicated additives can be used to generate a type C medicated feed.
It is considered to be “effective” against both gram-positive and gram-negative bacteria and can be used to address related diseases include ileitis, leptospirosis and jowl abscesses, the company said.
“Swine dysentery is not common, but it is a tough [disease] if a herd gets it and it’s a good combination,” Wilson added. “Enteritis is quite common, and the combination is good for that.”
Currently, the company is focusing on the US market, he said.
“The primary reason we went after this was this combination is in use and it’s business,” said Wilson. “We’re trying to make sure that produces and veterinarians don’t say, ‘You don’t have the combination that I’m looking for.’”
“If they’re looking for the combination to treat a disease I wanted to make sure I had it,” he added.
Previously, the company gained approvals for its generic chlortetracycline to be used in medicated cattle feed with lasalocid or decoquinate, he said.
The most recent approval is anticipated to complete the additive’s combined use portfolio.