Putney Launches Generic of Baytril® Taste Tabs®
Second FDA approval in four months demonstrates Putney's deep scientific
PORTLAND, Maine, April 29, 2013
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. NowI can, withPutney'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
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
SOURCE Putney, Inc.
Contact: Susan Hanley, Corporate Communications for Putney, 207-332-2443 or
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