[Federal Register: April 18, 2008 (Volume 73, Number 76)]
[Rules and Regulations]
[Page 21042-21043]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr18ap08-6]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 522
Implantation or Injectable Dosage Form New Animal Drugs; Insulin
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 supplemental new animal drug
application (NADA) filed by Intervet, Inc. The supplemental NADA
provides for the veterinary prescription use of an injectable
suspension of porcine insulin zinc for the reduction of hyperglycemia
and hyperglycemia-associated clinical signs in cats with diabetes
mellitus.
DATES: This rule is effective April 18, 2008.
FOR FURTHER INFORMATION CONTACT: Melanie R. Berson, Center for
Veterinary Medicine (HFV-110), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 240-276-8337, e-mail:
melanie.berson@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Intervet, Inc., P.O. Box 318, 29160 Intervet
Lane, Millsboro, DE 19966, filed a supplement to NADA 141-236 providing
for the veterinary prescription use of VETSULIN (porcine insulin zinc)
Suspension for the reduction of hyperglycemia and hyperglycemia-
associated clinical signs in cats with diabetes mellitus. The
application also provides for a lower initial dosage of insulin for
dogs. The supplemental NADA is approved as of March 24, 2008, and the
regulations are amended in 21 CFR 522.1160 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 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.
Under section 512(c)(2)(F)(iii) of the Federal Food, Drug, and
Cosmetic Act 21 U.S.C 360b(c)(2)(F)(iii)), this approval qualifies for
3 years of marketing exclusivity beginning on the date of approval. The
three years of marketing exclusivity applies only to the indication for
use in cats for which this supplement is approved.
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 522
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 522 is
amended as follows:
PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS
0
1. The authority citation for 21 CFR part 522 continues to read as
follows:
Authority: 21 U.S.C. 360b.
0
2. In Sec. 522.1160, revise paragraphs (a) and (c) to read as follows:
Sec. 522.1160 Insulin.
(a) Specifications. Each milliliter of porcine insulin zinc
suspension contains 40 international units (IU) of insulin.
* * * * *
(c) Conditions of use--(1) Dogs--(i) Amount. Administer an initial
once-daily dose of 0.5 IU per kilogram of body weight by subcutaneous
injection concurrently with or right after a meal. Adjust this once-
daily dose at appropriate intervals based on clinical signs, urinalysis
results, and glucose curve values until adequate glycemic control has
been attained. Twice-daily therapy should be initiated if the duration
of insulin action is determined to be inadequate. If twice-daily
treatment is initiated, the two doses should be 25 percent less than
the once daily dose required to attain an acceptable nadir.
(ii) Indications for use. For the reduction of hyperglycemia and
hyperglycemia-associated clinical signs in dogs with diabetes mellitus.
(iii) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.
(2) Cats--(i) Amount. Administer an initial dose of 1 to 2 IU by
subcutaneous
[[Page 21043]]
injection. Injections should be given twice daily at approximately 12-
hour intervals. For cats fed twice daily, the injections should be
concurrent with or right after a meal. For cats fed ad libitum, no
change in feeding is needed. Adjust the dose at appropriate intervals
based on clinical signs, urinalysis results, and glucose curve values
until adequate glycemic control has been attained.
(ii) Indications for use. For the reduction of hyperglycemia and
hyperglycemia-associated clinical signs in cats with diabetes mellitus.
(iii) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.
Dated: April 4, 2008.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. E8-8347 Filed 4-17-08; 8:45 am]
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