Putney Launches Generic of Baytril® Taste Tabs® Second FDA approval in four months demonstrates Putney's deep scientific capabilities
PORTLAND, Maine, April 29, 2013 /PRNewswire/ -- Putney, Inc., a rapidly growing pharmaceutical company focused on the development and sale of generic prescription medicines for pets, has launched Enrofloxacin Flavored Tablets, the first and only FDA approved veterinary generic of Baytril® Taste Tabs®. Putney's Enrofloxacin Flavored Tablets are indicated for the management of diseases associated with bacteria susceptible to enrofloxacin, such as urinary cystitis, respiratory tract infections and dermal infections in dogs and cats.
This is Putney's second major product launch of 2013, coming just two months after the company launched Putney Cefpodoxime Proxetil tablets, the first and only FDA approved veterinary generic of Simplicef®. Both products were scientifically challenging to develop as generics. The approval of Putney's Enrofloxacin Flavored Tablets is the first time the FDA has ever approved a product that demonstrated bioequivalence in cats. "The requirements for CVM approval are necessarily rigorous, and include stringent testing and control requirements, adherence to current good manufacturing practices (cGMP), and studies to demonstrate bioequivalence to the branded drug. To our knowledge, in the last five years FDA has approved only four generic animal drugs requiring bioequivalence and two of these were for Putney products," says Jennifer Johansson, Putney's Senior Vice President of Regulatory Policy and Counsel, who oversaw the ANADA approval by the FDA. Dr. Anthony Lucas, BVMS, Ph.D., Putney's Vice President of Product Development, adds that demonstrating bioequivalence is a significant barrier to most companies working to enter the U.S. veterinary generics market, especially for cats.
Jean Hoffman, Putney founder and CEO, says Putney will continue to apply its technical and FDA regulatory expertise, and leverage its global manufacturing partnerships to solve the scientific and regulatory challenges involved in providing veterinarians with affordable pet medicines. "Our investment in R&D, our commitment to high quality manufacturing in FDA-inspected facilities, and our ongoing veterinary medical services underscore Putney's support of veterinarians and their pet owner clients. With increased fiscal pressures on their practices, veterinarians are looking for companies that support them. Putney offers the quality and value veterinarians want with the cost savings pet owners need to comply with the vet's recommended treatment," says Hoffman.
Hoffman expects to grow the $25 million oral enrofloxacin market by capturing sales of alternative antibiotics that veterinarians prescribe in its place due to Baytril®'s high price. Despite it not being the same molecule, and its reduced effectiveness in dogs and cats, veterinarians often save pet owners money by prescribing a less expensive human-approved drug, ciprofloxacin, in place of Baytril®. "Using Baytril® Taste Tabs® to treat a urinary tract infection in a large dog, such as a Labrador retriever, costs a pet owner over $100—which makes cost a barrier to treatment. Putney's Enrofloxacin Flavored Tablets makes the treatment more affordable, so pets can get the right treatment the first time," says Hoffman.
Dr. Kathryn Utsey, DVM of Crossroads Veterinary Hospital agrees. "I prescribe ciprofloxacin for large dogs, which is not as bioavailable, but is a lot more affordable. I would like to go back to prescribing enrofloxacin in those situations. Now I can, with Putney's Enrofloxacin," says Dr. Utsey.
Putney currently has four FDA-approved veterinary generic products with a pipeline of over twenty more products in various stages of development and CVM review. For additional information, including the distributors through which Putney's products are available to licensed veterinarians, visit www.putneyvet.com.
Important Safety Information: Enrofloxacin Flavored Tablets should not be used in dogs and cats that are hypersensitive to quinolones. In rare instances use of this product in cats has been associated with Retinal Toxicity. Dosage should not exceed 5 mg/kg of body weight once daily in cats. See www.putneyvet.com website for complete indications, side effects, contraindications and other important product information.
Baytril® is a registered trademark of Bayer Aktiengesellschaft.
Taste Tab® is a registered trademark of Bayer Healthcare LLC.
Simplicef® is a registered trademark of PAH P&U LLC.
PUTNEY® and logo are registered trademarks of Putney, Inc. ©2013 Putney, Inc.
Putney is a pharmaceutical company committed to providing high quality, cost-effective generic medicines for pets. Putney's reliable supply of affordable drug options empowers veterinarians, allowing them to provide the best possible medicine at the best possible price, and supports pet owners, helping them afford to comply with veterinary recommendations. Putney's ongoing investment in research and development is focused on creating the next generation of generic veterinary products based on inputs from companion animal veterinarians and its industry partners. Learn more at www.putneyvet.com.
SOURCE Putney, Inc.