Document ID: FDA-2011-N-0003-0078
Agency: fda
Document Type: Rule
Title: Oral Dosage Form New Animal Drugs: Pergolide
Posted Date: 2012-03-19T04:00Z

[Federal Register Volume 77, Number 53 (Monday, March 19, 2012)]
[Rules and Regulations]
[Pages 15960-15961]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-6544]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 520

[Docket No. FDA-2011-N-0003]

Oral Dosage Form New Animal Drugs; Pergolide

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is amending the animal 
drug regulations to reflect approval of an original new animal drug 
application (NADA) filed by Boehringer Ingelheim Vetmedica, Inc. The 
NADA provides for the veterinary prescription use of pergolide mesylate 
tablets in horses for the control of clinical signs associated with 
Pituitary Pars Intermedia Dysfunction (Equine Cushing's Disease).

DATES: This rule is effective March 19, 2012.

FOR FURTHER INFORMATION CONTACT: Amy L. Omer, Center for Veterinary 
Medicine (HFV-114), Food and Drug Administration, 7500 Standish Pl., 
Rockville, MD 20855, 240-276-8336, email: amy.omer@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Boehringer Ingelheim Vetmedica, Inc., 2621 
North Belt Highway, St. Joseph, MO 64506-2002, filed NADA 141-331 for 
the veterinary prescription use in horses of PRASCEND (pergolide 
mesylate) Tablets for the control of clinical signs associated with 
Pituitary Pars Intermedia Dysfunction (Equine Cushing's Disease). The 
NADA is approved as of September 7, 2011, and 21 CFR part 520 is 
amended to reflect the approval.
    In accordance with the freedom of information provisions of 21 CFR 
part 20 and 21 CFR 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 Division of Dockets Management 
(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(c)(2)(F)(i) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360b(c)(2)(F)(i)), this approval qualifies for 
5 years of marketing exclusivity beginning on the date of approval.
    The Agency has determined under 21 CFR 25.33 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.
    This rule does not meet the definition of ``rule'' in 5 U.S.C. 
804(3)(A) because it is a rule of ``particular applicability.'' 
Therefore, it is not subject to the congressional review requirements 
in 5 U.S.C. 801-808.

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

0
1. The authority citation for 21 CFR part 520 continues to read as 
follows:

    Authority:  21 U.S.C. 360b.

0
2. Add Sec.  520.1705 to read as follows:

Sec.  520.1705  Pergolide.

    (a) Specifications. Each tablet contains 1 milligram (mg) pergolide 
mesylate.
    (b) Sponsor. See No. 000010 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use in horses--(1) Amount. Administer orally at a 
starting dose of 2 micrograms/kilograms ([mu]/kg) once daily. Dosage 
may be adjusted to effect, not to exceed 4 [mu]g/kg daily.
    (2) Indications for use. For the control of clinical signs 
associated with Pituitary Pars Intermedia Dysfunction (Equine Cushing's 
Disease).
    (3) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.

[[Page 15961]]

    Dated: March 14, 2012.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2012-6544 Filed 3-16-12; 8:45 am]
BILLING CODE 4160-01-P