[Federal Register Volume 61, Number 91 (Thursday, May 9, 1996)]
[Rules and Regulations]
[Page 21075]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-11511]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES
21 CFR Parts 510 and 522


Animal Drugs, Feeds, and Related Products; Medetomidine 
Hydrochloride Injection; Change of Sponsor Name

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 Orion Corp. ORION-FARMOS. The NADA provides for the use 
of medetomidine hydrochloride injection in dogs for its sedative and 
analgesic properties. The regulations are also amended to reflect a 
change of sponsor name.

EFFECTIVE DATE: May 9, 1996.

FOR FURTHER INFORMATION CONTACT: Sandra K. Woods, Center for Veterinary 
Medicine (HFV-114), Food and Drug Administration, 7500 Standish Pl., 
Rockville, MD 20855, 301-594-1616.

SUPPLEMENTARY INFORMATION: Orion Corp. ORION-FARMOS, (formerly Orion 
Corp. FARMOS), P.O. Box 425, SF-20101 Turku, Finland, filed NADA 140-
999, which provides for intravenous or intramuscular use of 
Domitor (medetomidine hydrochloride) injection as a sedative 
and analgesic in dogs over 12 weeks of age to facilitate clinical 
examinations, clinical procedures, minor surgical procedures not 
requiring muscle relaxation, and minor dental procedures not requiring 
intubation. The drug product is available by prescription. The 
application is approved as of March 19, 1996, and the regulations are 
amended in part 522 (21 CFR part 522) by adding new Sec. 522.1335 to 
reflect the approval. The basis of approval is discussed in the freedom 
of information summary.
    Additionally, the firm has informed FDA that it has changed its 
corporate name from Orion Corp. FARMOS to Orion Corp. ORION-FARMOS. 
Accordingly, the agency is also amending 21 CFR 510.600(c)(1) and 
(c)(2) to reflect the change of sponsor name.
    In accordance with the freedom of information provisions of part 20 
(21 CFR part 20) and Sec. 514.11(e)(2)(ii) (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 Dockets 
Management Branch (HFA-305), Food and Drug Administration, 12420 
Parklawn Dr., rm. 1-23, Rockville, MD 20857, 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 March 19, 1996, because no 
active ingredient (including any ester or salt of the active 
ingredient) of the drug has been approved in any other application 
under section 512(b)(1) of the act.
    The agency has carefully considered the potential environmental 
effects of this action. FDA has concluded that the action will not have 
a significant impact on the human environment, and that an 
environmental impact statement is not required. The agency's finding of 
no significant impact and the evidence supporting that finding, 
contained in an environmental assessment, may be seen in the Dockets 
Management Branch (address above) between 9 a.m. and 4 p.m., Monday 
through Friday.

List of Subjects

21 CFR Part 510-

    Administrative practice and procedure, Animal drugs, Labeling, 
Reporting and recordkeeping requirements.

21 CFR Part 522-

    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 parts 510 and 
522 are amended as follows:

PART 510--NEW ANIMAL DRUGS

    1. The authority citation for 21 CFR part 510 continues to read as 
follows:

    Authority: Secs. 201, 301, 501, 502, 503, 512, 701, 721 of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321, 331, 351, 352, 
353, 360b, 371, 379e).


Sec. 510.600  [Amended]

    2. Section 510.600 Names, addresses, and drug labeler codes of 
sponsors of approved applications is amended in the table in paragraph 
(c)(1) by removing the sponsor name ``Orion Corp. FARMOS, Research and 
Development, Pharmaceuticals,'' and by adding in its place ``Orion 
Corp. ORION-FARMOS'', and in the table in paragraph (c)(2) in the entry 
for ``052483'' by removing the sponsor name ``Orion Corp. FARMOS, 
Research and Development, Pharmaceuticals,'' and adding in its place 
``Orion Corp. ORION-FARMOS''.

PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS

    3. The authority citation for 21 CFR part 522 continues to read as 
follows:

    Authority: Sec. 512 of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 360b).

    4. New Sec. 522.1335 is added to read as follows:


Sec. 522.1335  Medetomidine hydrochloride injection.

    (a) Specifications. Each milliliter of sterile aqueous solution 
contains 1.0 milligram of medetomidine hydrochloride.
    (b) Sponsor. See 052483 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use--(1) Amount. 750 micrograms intravenously 
(IV) or 1,000 micrograms intramuscularly per square meter of body 
surface. The IV route is more efficacious for dental care.
    (2) Indications for use. As a sedative and analgesic in dogs over 
12 weeks of age to facilitate clinical examinations, clinical 
procedures, minor surgical procedures not requiring muscle relaxation, 
and minor dental procedures not requiring intubation. The intravenous 
route of administration is more efficacious for dental care.
    (3) Limitations. Do not use in dogs with cardiac disease, 
respiratory disorders, liver or kidney diseases, dogs in shock, dogs 
which are severly debilitated, or dogs which are stressed due to 
extreme heat, cold, or fatigue. Allow agitated dogs to rest quietly 
before administration. Do not repeat dosing in dogs not responding 
satisfactorily to treatment. Do not use in breeding or pregnant 
animals. Federal law restricts this drug to use by or on the order of a 
licensed veterinarian.

    Dated: April 15, 1996.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 96-11511 Filed 5-8-96; 8:45 am]
BILLING CODE 4160-01-F