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Drug Maker Putney Celebrates Regulatory Successes

Portland, Maine, company has won five FDA approvals of generic animal drugs over the past five months.

Two new generic drugs from Putney Inc. are Enrofloxacin Antibacterial Injectable Solution and Carprofen Chewable Tablets.

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Fresh off government approval of four generic animal drugs, manufacturer Putney Inc. this week reported receiving the go-ahead for a fifth: Enrofloxacin Antibacterial Injectable Solution.

The generic version of Bayer Animal Health’s Baytril Antibacterial Injectable Solution is indicated for the treatment of bacterial infections in dogs. The Putney drug won the approval of the U.S. Food and Drug Administration’s Center for Veterinary Medicine, giving the company its fifth FDA endorsement in five months.

Putney President and CEO Jean Hoffman credited the Portland, Maine, company’s research and development team for the recent approvals.

“Only six generic pet medicines were approved by the FDA in 2014, and four of them were Putney products,” Hoffman said.

The latest achievement made Putney the only manufacturer with an FDA-approved generic of enrofloxacin for pets in both flavored tablet and injectable dosage forms. The company’s Enrofloxacin Flavored Tablets are formulated for dog and cats.

A rollout date for Enrofloxacin Injectable Solution was not announced.

Three of the four Putney drugs approved in 2014—Dexmedetomidine HCl, Meloxicam Solution for Injection and Carprofen Chewable Tablets—are in veterinary pharmacies. The fourth, Carprofen Sterile Injectable Solution, is expected to be released soon, the company stated.

Putney’s last approved drug of 2014, Carprofen Chewable Tablets, is the generic version of Zoetis Inc.’s Rimadyl Chewable Tablets. Both canine medications are indicated for the relief of osteoarthritis pain and inflammation and for the control of postoperative pain.

Putney promotes a 30 percent cost savings for veterinarians when Carprofen Chewable Tablets are prescribed over the brand-name equivalent.

“Pet owners faced with the expense of a long-term medicine for a chronic condition wish they could afford to comply with their veterinarian’s recommendation to give their pet the recommended medicine every day, but the expense of many pet drugs is a problem,” Hoffman said.

Putney drug applications are winning faster approval, said Jennifer Johansson, senior vice president of regulatory policy.

“We’ve made a significant investment to ensure the high quality of our FDA submissions,” Johansson said.

A 45 percent jump in revenue in 2014 shows that Putney is growing rapidly, Hoffman said.

“We expect to surpass that level of revenue growth in 2015 as our newly launched products are adopted by veterinarians,” she said.

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