Oral Dosage Form New Animal Drugs; Dirlotapide, 262-263 [E6-22542]

Download as PDF 262 Federal Register / Vol. 72, No. 2 / Thursday, January 4, 2007 / Rules and Regulations 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. I 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 1. The authority citation for 21 CFR part 520 continues to read as follows: I Authority: 21 U.S.C. 360b. 2. In § 520.455, revise the section heading and paragraph (a) to read as follows: I § 520.455 Clomipramine tablets. (a) Specifications. Each tablet contains 5, 20, 40, or 80 milligrams (mg) clomipramine hydrochloride. * * * * * Dated: December 19, 2006. Steven D. Vaughn, Director, Office of New Animal Drug Evaluation, Center for Veterinary Medicine. [FR Doc. E6–22509 Filed 1–3–07; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES used in swine drinking water for the treatment of respiratory disease. DATES: Joan C. Gotthardt, Center for Veterinary Medicine (HFV–130), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301–827–7571, email: joan.gotthardt@fda.hhs.gov. FOR FURTHER INFORMATION CONTACT: ScheringPlough Animal Health Corp., 556 Morris Ave., Summit NJ 07901, filed a supplement to NADA 141–206 for NUFLOR (florfenicol) 2.3% Concentrate Solution used to make medicated drinking water for administration to swine for the treatment of respiratory disease associated with several bacterial pathogens. The supplemental NADA revises the nomenclature for a respiratory pathogen in the label claim. The supplemental NADA is approved as of December 8, 2006, and the regulations in 21 CFR 520.955 are amended to reflect the approval. Approval of this supplemental NADA did not require review of additional safety or effectiveness data or information. Therefore, a freedom of information summary is not required. The agency has determined under 21 CFR 25.33(a)(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. SUPPLEMENTARY INFORMATION: List of Subjects in 21 CFR Part 520 Food and Drug Administration Animal drugs. 21 CFR Part 520 Food and Drug Administration, HHS. ACTION: Final rule. The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA) filed by Schering-Plough Animal Health Corp. The supplemental NADA revises the nomenclature for a respiratory pathogen in the label claim for florfenicol when pwalker on PROD1PC65 with RULES SUMMARY: VerDate Aug<31>2005 00:35 Jan 04, 2007 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: I Oral Dosage Form New Animal Drugs; Florfenicol AGENCY: This rule is effective January 4, 2007. Jkt 211001 PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS 1. The authority citation for 21 CFR part 520 continues to read as follows: I Authority: 21 U.S.C. 360b. § 520.955 [Amended] 2. In paragraph (d)(2) of § 520.955, remove the words ‘‘Type 2’’. I PO 00000 Frm 00016 Fmt 4700 Sfmt 4700 Dated: December 21, 2006. Steven D. Vaughn, Director, Office of New Animal Drug Evaluation, Center for Veterinary Medicine. [FR Doc. E6–22516 Filed 12–29–06; 8:45 am] BILLING CODE 4160–01–S 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. 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, email: 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 § 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 E:\FR\FM\04JAR1.SGM 04JAR1 Federal Register / Vol. 72, No. 2 / Thursday, January 4, 2007 / Rules and Regulations 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. 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: I PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS 1. The authority citation for 21 CFR part 520 continues to read as follows: I Authority: 21 U.S.C. 360b. 2. Section 520.666 is added to read as follows: I § 520.666 Dirlotapide. pwalker on PROD1PC65 with RULES (a) Specifications. Each milliliter (mL) of solution contains 5 milligrams (mg) dirlotapide. (b) Sponsor. See No. 000069 in § 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] BILLING CODE 4160–01–S VerDate Aug<31>2005 00:35 Jan 04, 2007 Jkt 211001 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 522 Implantation or Injectable Dosage Form New Animal Drugs; Dexmedetomidine AGENCY: Food and Drug Administration, approval qualifies for 3 years of marketing exclusivity beginning December 1, 2006. 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 Parts 522 HHS. ACTION: Animal drugs. Final rule. 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 Orion Corp. The NADA provides for veterinary prescription use of dexmedetomidine hydrochloride injectable solution as a sedative, analgesic, and preanesthetic in dogs. 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, email: melanie.berson@fda.hhs.gov. SUPPLEMENTARY INFORMATION: Orion Corp., Orionintie 1, 02200 Espoo, Finland, filed NADA 141–267 for DEXDOMITOR (dexmedetomidine hydrochloride). The NADA provides for the veterinary prescription use of dexmedetomidine hydrochloride injectable solution as a sedative, analgesic, and preanesthetic in dogs. The application is approved as of December 1, 2006, and 21 CFR part 522 is amended by adding new § 522.558 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. The agency has determined under § 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. Under section 512(c)(2)(F)(ii) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360b(c)(2)(F)(ii)), this SUMMARY: PO 00000 Frm 00017 Fmt 4700 263 Sfmt 4700 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 522 is amended as follows: I PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS 1. The authority citation for 21 CFR part 522 continues to read as follows: I Authority: 21 U.S.C. 360b. I 2. Add § 522.558 to read as follows: § 522.558 Dexmedetomidine. (a) Specifications. Each milliliter of solution contains 10 milligrams (mg) dexmedetomidine hydrochloride. (b) Sponsor. See No. 052483 in § 510.600(c) of this chapter. (c) Conditions of use in dogs—(1) Indications for use and amount—(i) For use as a sedative and analgesic in dogs to facilitate clinical examinations, clinical procedures, minor surgical procedures, and minor dental procedures, administer 375 micrograms (µg) per square meter (/m2) of body surface area by intravenous injection or 500 µg/m2 of body surface area by intramuscular injection. (ii) For use as a preanesthetic to general anesthesia, administer 125 µg/ m2 of body surface area or 375 µg/m2 of body surface area by intramuscular injection. (2) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Dated: December 19, 2006. Stephen F. Sundlof, Director, Center for Veterinary Medicine. [FR Doc. E6–22508 Filed 1–3–07; 8:45 am] BILLING CODE 4160–01–S E:\FR\FM\04JAR1.SGM 04JAR1

Agencies

[Federal Register Volume 72, Number 2 (Thursday, January 4, 2007)]
[Rules and Regulations]
[Pages 262-263]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-22542]


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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

0
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]
BILLING CODE 4160-01-S

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