Document ID: FDA-2011-N-0003-0079
Agency: fda
Document Type: Rule
Title: Oral Dosage Form New Animal Drugs: Phenylpropanolamine
Posted Date: 2012-03-19T04:00Z

[Federal Register Volume 77, Number 53 (Monday, March 19, 2012)]
[Rules and Regulations]
[Page 15961]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-6553]

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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; Phenylpropanolamine

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 an original new animal drug 
application (NADA) filed by Pegasus Laboratories, Inc. The NADA 
provides for the veterinary prescription use of phenylpropanolamine 
hydrochloride chewable tablets for the control of urinary incontinence 
due to urethral sphincter hypotonus in dogs.

DATES: This rule is effective March 19, 2012.

FOR FURTHER INFORMATION CONTACT: Lisa M. Troutman, Center for 
Veterinary Medicine (HFV-116), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 240-276-8322, email: 
lisa.troutman@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Pegasus Laboratories, Inc., 8809 Ely Rd., 
Pensacola, FL 32514, filed NADA 141-324 that provides for the 
veterinary prescription use of PROIN (phenylpropanolamine 
hydrochloride) Chewable Tablets for the control of urinary incontinence 
due to urethral sphincter hypotonus in dogs. The NADA is approved as of 
August 4, 2011, and the regulations are amended in 21 CFR part 520 to 
reflect the approval.
    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.
    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.
    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.
    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.  520.1760 to read as follows:

Sec.  520.1760  Phenylpropanolamine.

    (a) Specifications. Each chewable tablet contains 25, 50, or 75 
milligram (mg) phenylpropanolamine hydrochloride.
    (b) Sponsors. See No. 055246 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use in dogs--(1) Amount. Administer 2 mg/kg of 
body weight twice daily.
    (2) Indications for use. For the control of urinary incontinence 
due to urethral sphincter hypotonus in dogs.
    (3) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.

    Dated: March 14, 2012.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2012-6553 Filed 3-16-12; 8:45 am]
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