PIEDMONT ANIMAL HEALTH RECEIVES FDA APPROVAL FOR BAYTRIL® SOFT CHEWS (enrofloxacin)
GREENSBORO, N.C., July 30, 2018 – Piedmont Animal Health announces its Food and Drug Administration (FDA) approval for an ANADA companion animal product. The product, Baytril® (enrofloxacin) Soft Chewable Tablet, is a convenient generic of Baytril Tablets® and is the third soft chew developed and approved in the U.S. for Bayer Animal Health in the soft chew platform invented by Piedmont.
This product is also the fourth Piedmont companion animal product to be approved by the U.S. FDA for Bayer Animal Health in the last five years.
- In 2013, Piedmont received FDA approval of quellin® (carprofen) soft chew, a generic equivalent to the pain medication RIMADYL® (carprofen)
- In 2015, Piedmont received the FDA approval of the new drug applications (NADA) for advantus® (imidacloprid) soft chew for flea control
- Piedmont also received FDA approval in 2015 for Claro™ (mometasone, florfenicol, terbinafine), a single application treatment for otitis externa. Claro is the fastest growing otitis externa product in the U.S. and is the only ear infection treatment for dogs that requires one dose per ear.
Bayer’s enrofloxacin formulations are some of the most commonly prescribed antibiotics used for companion animals globally.
Piedmont has a robust pipeline of primarily companion animal products in development. Most of Piedmont’s portfolio are proprietary and uniquely performing products targeting the major companion animal indication areas of antibiotics, chronic kidney disease and pain. Piedmont is projecting the FDA approval of ten or more products in the next five years.
“I fully expect that Piedmont’s current portfolio of proprietary drugs will significantly grow and disrupt the indication areas we are targeting” adds Roland Johnson, Piedmont’s CEO and Founder. “This approval is yet another stepping stone towards that objective.”
ABOUT PIEDMONT ANIMAL HEALTH
Piedmont Animal Health is led by a team of experienced veterinary pharmaceutical innovators who have over their careers developed, launched, or marketed more than 19 companion animal health FDA approved Rx or OTC products. A leader in innovation, Piedmont is dedicated to developing products that improve compliance and ease of use.
For more information, visit PiedmontAnimalHealth.com.