NADA Number: 141-188
Marquis® Antiprotozoal Oral Paste
3239 Satellite Blvd.
Duluth, GA 30096-4640
(Horse, not for meat production)
|Routes of Administration||
|Patent Number (Expiration Date)||
(No Expiration Date)
5883095 (No Expiration Date)
This supplemental approval for Marquis® Oral Paste qualifies for THREE years of marketing exclusivity under section 512(c)(2)(F)(iii) of the Federal Food, Drug, and Cosmetic Act because the supplemental application included a study of safety and effectiveness. This exclusivity begins as of the date of our approval letter and only applies to the revised dosage regimen to include a loading dose (Expires 5/21/2018).
Specifications: Each gram of paste contains 150 milligrams (mg) ponazuril.
Amount: Administer at a dose of 15 mg/kg (6.81 mg/lb) body weight as a loading dose for the first dose only. The loading dose is followed by a maintenance dose of 5 mg/kg (2.27 mg/lb) body weight once daily for a period of 27 additional days.
Indications: For the treatment of equine protozoal myeloencephalitis (EPM) caused by Sarcocystis neurona.
Limitations: Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian.