[Federal Register Volume 63, Number 84 (Friday, May 1, 1998)]
[Rules and Regulations]
[Pages 24105-24106]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-11685]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 510 and 529
Certain Other Dosage Form New Animal Drugs; Isoflurane
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 an abbreviated new animal drug
application (ANADA) filed by Marsam Pharmaceuticals, Inc. The ANADA
provides for inhalational use of isoflurane USP for induction and
maintenance of general anesthesia in horses and dogs.
EFFECTIVE DATE: May 1, 1998.
FOR FURTHER INFORMATION CONTACT: Lonnie W. Luther, Center for
Veterinary Medicine (HFV-102), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 301-827-0209.
SUPPLEMENTARY INFORMATION: Marsam Pharmaceuticals, Inc., Bldg. 31, 24
Olney Ave., Cherry Hill, NJ 08034, filed ANADA 200-187 that provides
for inhalational use of isoflurane USP for induction and maintenance of
general anesthesia in horses and dogs. The drug is limited to use by or
on the order of a licensed veterinarian.
Approval of ANADA 200-187 for Marsam Pharmaceuticals, Inc.'s,
isoflurane is as a generic copy of Ohmeda Pharmaceutical Product's NADA
135-773 AErrane (isoflurane, USP). The ANADA is approved as
of February 11, 1998, and the regulations are amended in 21 CFR
529.1186(b) to reflect the approval. The basis of approval is discussed
in the freedom of information summary.
In addition, Marsam Pharmaceuticals, Inc., has not been previously
listed in Sec. 510.600 (21 CFR 510.600) as sponsor of an approved
application. The regulations are amended in Sec. 510.600(c)(1) and
(c)(2) to reflect the new sponsor.
In accordance with the freedom of information provisions of 21 CFR
part 20 and 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 20855,
between 9 a.m. and 4 p.m., Monday through Friday.
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.
List of Subjects
21 CFR Part 510
Administrative practice and procedure, Animal drugs, Labeling,
Reporting and recordkeeping requirements.
21 CFR Part 529
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
529 are amended as follows:
PART 510--NEW ANIMAL DRUGS
1. The authority citation for 21 CFR part 510 continues to read as
follows:
[[Page 24106]]
Authority: 21 U.S.C. 321, 331, 351, 352, 353, 360b, 371, 379e.
2. Section 510.600 is amended in the table in paragraph (c)(1) by
alphabetically adding an entry for ``Marsam Pharmaceuticals, Inc.,''
and in the table in paragraph (c)(2) by numerically adding an entry for
``000209'' to read as follows:
Sec. 510.600 Names, addresses, and drug labeler codes of sponsors of
approved applications.
* * * * *
(c) * * *
(1) * * *
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Firm name and address Drug labeler code
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* * * * * *
*
Marsam Pharmaceuticals, Inc., Bldg. 31, 24 Olney Ave., 000209
Cherry Hill, NJ 08034.
* * * * * *
*
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(2) * * *
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Drug labeler code Firm name and address
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* * * * * *
*
000209 Marsam Pharmaceuticals, Inc., Bldg. 31, 24 Olney Ave.,
Cherry Hill, NJ 08034.
* * * * * *
*
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PART 529--CERTAIN OTHER DOSAGE FORM NEW ANIMAL DRUGS
1. The authority citation for 21 CFR part 529 continues to read as
follows:
Authority: 21 U.S.C. 360b.
2. Section 529.1186 is amended by revising paragraph (b) to read as
follows:
Sec. 529.1186 Isoflurane.
* * * * *
(b) Sponsors. See Nos. 000074, 000209, 010019, 012164, and 059258
in Sec. 510.600(c) of this chapter.
* * * * *
Dated: April 22, 1998.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 98-11685 Filed 4-30-98; 8:45 am]
BILLING CODE 4160-01-F