[Federal Register Volume 63, Number 46 (Tuesday, March 10, 1998)]
[Rules and Regulations]
[Pages 11597-11598]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-6080]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 510 and 522
Implantation or Injectable Dosage Form New Animal Drugs;
Hemoglobin Glutamer-200 (Bovine)
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 Biopure Corp. The NADA provides for the use of
hemoglobin glutamer-200 (bovine) for the treatment of anemia in dogs.
EFFECTIVE DATE: March 10, 1998.
FOR FURTHER INFORMATION CONTACT: Melanie R. Berson, Center for
Veterinary Medicine (HFV-110), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 301-594-1612.
SUPPLEMENTARY INFORMATION: Biopure Corp., 11 Hurley St., Cambridge, MA
02141, is the sponsor of NADA 141-067 that provides for the use of
Oxyglobin (hemoglobin glutamer-200 (bovine)) for the
treatment of anemia in dogs by increasing systemic oxygen content
(plasma hemoglobin concentration) and improving the clinical signs
associated with anemia for at least 24 hours, regardless of the cause
of anemia (hemolysis, blood loss, or ineffective erythropoiesis). The
drug is limited to use by or on the order of a licensed veterinarian.
The NADA is approved as of January 28, 1998, and the regulations are
amended by adding Sec. 522.1125 to reflect the approval. The basis of
approval is discussed in the freedom of information summary.
In addition, Biopure Corp. has not been previously listed in the
animal drug regulations as sponsor of an approved application. At this
time, 21 CFR 510.600(c) is amended to add entries for the firm.
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 20857,
between 9 a.m. and 4 p.m., Monday through Friday.
The agency has determined under 21 CFR 25.33(d)(5) 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)(i) of the Federal Food, Drug, and
Cosmetic Act, this approval for nonfood-producing animals qualifies for
5 years of marketing exclusivity beginning January 28, 1998, because no
active ingredient of the drug (including any salt or ester of the
active ingredient) has been approved in any other application.
[[Page 11598]]
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: 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 a new entry for ``Biopure Corp.'' and in the
table in paragraph (c)(2) by numerically adding a new entry for
``063075'' to read as follows:
Sec. 510.600 Names, addresses, and drug labeler codes of sponsors of
approved applications.
* * * * *
(c) * * *
(1) * * *
----------------------------------------------------------------------------------------------------------------
Firm name and address Drug labeler code
----------------------------------------------------------------------------------------------------------------
* * * * * *
*
Biopure Corp., 11 Hurley St., Cambridge, MA 02141. 063075
* * * * * *
*
----------------------------------------------------------------------------------------------------------------
(2) * * *
----------------------------------------------------------------------------------------------------------------
Drug labeler code Firm name and address
----------------------------------------------------------------------------------------------------------------
063075 Biopure Corp., 11 Hurley St., Cambridge, MA 02141.
* * * * * *
*
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PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS
1. The authority citation for 21 CFR part 522 continues to read as
follows:
Authority: 21 U.S.C. 360b.
2. Section 522.1125 is added to read as follows:
Sec. 522.1125 Hemoglobin glutamer-200 (bovine).
(a) Specifications. Each 125 milliliter bag contains 13 grams per
deciliter of polymerized hemoglobin of bovine origin in modified
Lactated Ringer's Solution. It is a sterile, clear, dark purple
solution.
(b) Sponsor. See No. 063075 in Sec. 510.600(c) of this chapter.
(c) [Reserved]
(d) Conditions of use-- (1) Amount. One-time dose of 30 milliliters
per kilogram of body weight administered intravenously at a rate of up
to 10 milliliters per kilogram per hour.
(2) Indications for use. For the treatment of anemia in dogs by
increasing systemic oxygen content (plasma hemoglobin concentration)
and improving the clinical signs associated with anemia for at least 24
hours, regardless of the cause of anemia (hemolysis, blood loss, or
ineffective erythropoiesis).
(3) Limitations. For intravenous use only. Overdosage or an
excessive rate of administration (greater than 10 milliliters per
kilogram per hour) may result in circulatory overload. Federal law
restricts this drug to use by or on the order of a licensed
veterinarian.
Dated: February 27, 1998.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 98-6080 Filed 3-9-98; 8:45 am]
BILLING CODE 4160-01-F
