[Federal Register: January 4, 2007 (Volume 72, Number 2)]
[Rules and Regulations]
[Page 262-263]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr04ja07-8]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 520
Oral Dosage Form New Animal Drugs; Dirlotapide
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 Pfizer, Inc. The NADA provides for the veterinary
prescription use of dirlotapide solution in dogs for the management of
obesity.
DATES: This rule is effective January 4, 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: Pfizer, Inc., 235 East 42d St., New York, NY
10017-5755, filed NADA 141-260 for SLENTROL (dirlotapide) Oral
Solution. The NADA provides for the veterinary prescription use of
dirlotapide solution in dogs for the management of obesity. The
application is approved as of December 12, 2006, and the regulations
are amended in 21 CFR part 520 by adding new Sec. 520.666 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
[[Page 263]]
marketing exclusivity beginning December 12, 2006.
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.
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.
0
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
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1. The authority citation for 21 CFR part 520 continues to read as
follows:
Authority: 21 U.S.C. 360b.
0
2. Section 520.666 is added to read as follows:
Sec. 520.666 Dirlotapide.
(a) Specifications. Each milliliter (mL) of solution contains 5
milligrams (mg) dirlotapide.
(b) Sponsor. See No. 000069 in Sec. 510.600(c) of this chapter.
(c) Conditions of use in dogs--(1) Amount. The initial dosage is
0.01 mL/kg (0.0045 mL/lb) body weight for the first 14 days. After the
first 14 days of treatment, the dose volume is doubled to 0.02 mL/kg
(0.009 mL/lb) body weight for the next 14 days (days 15 to 28 of
treatment). Dogs should be weighed monthly and the dose volume adjusted
every month, as necessary, to maintain a target percent weight loss
until the desired weight is achieved.
(2) Indications for use. For the management of obesity.
(3) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.
Dated: December 20, 2006.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. E6-22542 Filed 1-3-07; 8:45 am]
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