[Federal Register: February 12, 2007 (Volume 72, Number 28)]
[Rules and Regulations]
[Page 6463]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr12fe07-8]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 520
Oral Dosage Form New Animal Drugs; Fluoxetine
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 Elanco Animal Health. The NADA provides for veterinary
prescription use of fluoxetine hydrochloride chewable tablets for the
treatment of canine separation anxiety.
DATES: This rule is effective February 12, 2007.
FOR FURTHER INFORMATION CONTACT: Melanie R. Berson, Center for
Veterinary Medicine (HFV-110), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 301-827-7540, e-mail:
melanie.berson@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Elanco Animal Health, A Division of Eli
Lilly & Co., Lilly Corporate Center, Indianapolis, IN 46285, filed NADA
141 272 that provides for veterinary prescription use of RECONCILE
(fluoxetine hydrochloride) Chewable Tablets for the treatment of canine
separation anxiety in conjunction with a behavior modification plan.
The NADA is approved as of January 19, 2007, and the regulations in
part 520 (21 CFR part 520) are amended by adding new Sec. 520.980 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 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 January 19, 2007.
FDA 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.
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.
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Therefore, under the Federal Food, Drug, and Cosmetic Act and under the
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
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1. The authority citation for 21 CFR part 520 continues to read as
follows:
Authority: 21 U.S.C. 360b.
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2. Add Sec. 520.980 to read as follows:
Sec. 520.980 Fluoxetine.
(a) Specifications. Each chewable tablet contains 8, 16, 32, or 64
milligrams (mg) fluoxetine hydrochloride.
(b) Sponsor. See No. 000986 in Sec. 510.600 of this chapter.
(c) Conditions of use in dogs--(1) Amount. 1 to 2 mg per kilogram
body weight once daily.
(2) Indications for use. For the treatment of canine separation
anxiety in conjunction with a behavior modification plan.
(3) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.
Dated: January 31, 2007.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. E7-2172 Filed 2-9-07; 8:45 am]
BILLING CODE 4160-01-S