Code of Federal Regulation for Incurin (Estriol) tablet

Oral Dosage Form New Animal Drugs; Estriol

A Rule by the Food and Drug Administration on 12/16/2011

Publication Date:

Friday, December 16, 2011

Agencies:

Department of Health and Human Services

Food and Drug Administration

Dates:

This rule is effective December 16, 2011.

Effective Date:

12/16/2011

Entry Type:

Rule

Document Citation:

76 FR 78149

Page:

78149 -78150 (2 pages)

CFR:

21 CFR 520

Agency/Docket Number:

Docket No. FDA-2011-N-0003

Document Number:

2011-32214

Shorter URL:

https://federalregister.gov/a/2011-32214

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 Intervet, Inc. The NADA provides for the veterinary prescription use of estriol tablets for the control of estrogen-responsive urinary incontinence in ovariohysterectomized female dogs.Show citation box

Table of Contents

• DATES:
• FOR FURTHER INFORMATION CONTACT:
• SUPPLEMENTARY INFORMATION:
• List of Subjects in 21 CFR Part 520

DATES: Back to Top

This rule is effective December 16, 2011.

FOR FURTHER INFORMATION CONTACT: Back to Top

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: Back to Top

Intervet, Inc., 556 Morris Ave., Summit, NJ 07901, filed NADA 141-325 that provides for the veterinary prescription use of INCURIN (estriol) Tablets for the control of estrogen-responsive urinary incontinence in ovariohysterectomized female dogs. The NADA is approved as of July 24, 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.Show citation box

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 Back to Top

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 Back to Top

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

Authority: Back to Top

21 U.S.C. 360b.Show citation box

2. Add § 520.852 to read as follows:

§ 520.852 Estriol.

(a) Specifications. Each tablet contains 1 milligram (mg) estriol.

(b) Sponsor. See No. 000061 in § 510.600(c) of this chapter.

(c) Conditions of use in dogs—(1) Amount. Administer at an initial dose of 2 mg per dog per day. The dosage may be titrated to as low as 0.5 mg per dog every second day, depending on response.

(2) Indications for use. For the control of estrogen-responsive urinary incontinence in ovariohysterectomized female dogs.

(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Dated: December 9, 2011.

Bernadette Dunham,

Director, Center for Veterinary Medicine.

[FR Doc. 2011-32214 Filed 12-15-11; 8:45 am]