[Federal Register Volume 64, Number 72 (Thursday, April 15, 1999)]
[Rules and Regulations]
[Pages 18572-18573]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-9455]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 520


Oral Dosage Form New Animal Drugs; Omeprazole

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is amending the animal 
drug regulations to reflect approval of a new animal drug application 
(NADA) filed by Merial Ltd. The NADA provides for oral use of 
omeprazole for the treatment and prevention of recurrence of gastric 
ulcers in horses and foals 4 weeks of age and older.

EFFECTIVE DATE: April 15, 1999.

FOR FURTHER INFORMATION CONTACT: Melanie R. Berson, Center for 
Veterinary Medicine (HFV-110), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-827-7543.

SUPPLEMENTARY INFORMATION: Merial Ltd., 2100 Ronson Rd., Iselin, NJ 
08830-3077, filed NADA 141-123 that provides for oral, veterinary 
prescription use of GastroGard (omeprazole) oral paste for 
horses and foals 4 weeks of age and older for the treatment and 
prevention of recurrence of gastric ulcers. The NADA is approved as of 
March 16, 1999, and the regulations are amended by adding 21 CFR 
520.1615 to reflect the approval. The basis of approval is discussed in 
the freedom of information summary.
     In accordance with the freedom of information provisions of 21 CFR 
part 20 and 514.11(e)(2)(ii), a summary of safety and effectiveness 
data and information submitted to support approval of this application 
may be seen in the Dockets Management Branch (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852, 
between 9 a.m. and 4 p.m., Monday through Friday.
     Under section 512 of the Federal, Food, Drug and Cosmetic Act (the 
act) (21 U.S.C. 360b(c)(2)(F)(i)), this approval qualifies for 5 years 
of marketing exclusivity beginning March 16, 1999, because no active 
ingredient

[[Page 18573]]

(including any ester or salt thereof) has been previously approved in 
any other application filed under section 512(b)(1) of the act.
     The agency has determined under 21 CFR 25.33(d)(1) that this 
action is of a type that does not individually or cumulatively have a 
significant effect on the human environment. Therefore, neither an 
environmental assessment nor an environmental impact statement is 
required.

List of Subjects in 21 CFR Part 520

     Animal drugs.
     Therefore, under the Federal Food, Drug, and Cosmetic Act and 
under authority delegated to the Commissioner of Food and Drugs and 
redelegated to the Center for Veterinary Medicine, 21 CFR part 520 is 
amended as follows:

PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS

     1. The authority citation for 21 CFR part 520 continues to read as 
follows:

    Authority: 21 U.S.C. 360b.
     2. Section 520.1615 is added to read as follows:

Sec. 520.1615   Omeprazole.

     (a) Specifications. Each gram of oral paste contains 0.37 gram of 
omeprazole.
     (b) Sponsor. See No. 050604 in Sec. 510.600(c) of this chapter.
     (c) [Reserved]
     (d) Conditions of use--(1) Amount. For treatment of gastric 
ulcers, 1.8 milligrams of omeprazole per pound of body weight (4 
milligrams per kilogram) once daily for 4 weeks. For prevention of 
recurrence of gastric ulcers, 0.9 milligram of omeprazole per pound of 
body weight (2 milligrams per kilogram) once daily for at least an 
additional 4 weeks.
     (2) Indications for use. For treatment and prevention of 
recurrence of gastric ulcers in horses and foals 4 weeks of age and 
older.
     (3) 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.

    Dated: April 1, 1999.
George A. Mitchell,
Acting Director, Center for Veterinary Medicine.
[FR Doc. 99-9455 Filed 4-14-99; 8:45 am]
BILLING CODE 4160-01-F