[Federal Register Volume 61, Number 113 (Tuesday, June 11, 1996)]
[Rules and Regulations]
[Pages 29480-29481]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-14644]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
21 CFR Part 522
Implantation or Injectable Dosage Form New Animal Drugs;
Tripelennamine Hydrochloride Injection
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 Phoenix Scientific, Inc. The ANADA
provides for use of tripelennamine hydrochloride injection in cattle
and horses for conditions in which antihistaminic therapy may be
expected to lead to alleviation of some signs of disease.
EFFECTIVE DATE: June 11, 1996.
FOR FURTHER INFORMATION CONTACT: Melanie R. Berson, Center for
Veterinary Medicine (HFV-135), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 301-594-1643.
SUPPLEMENTARY INFORMATION: Phoenix Scientific, Inc., 3915 South 48th
Street Ter., P.O. Box 6457, St. Joseph, MO 64506-0457, filed ANADA 200-
162 which provides for intravenous and intramuscular use in cattle and
intramuscular use in horses of tripelennamine hydrochloride injection
for conditions in which antihistaminic therapy is indicated. The drug
is limited to use by or on the order of a licensed veterinarian.
Approval of ANADA 200-162 for Phoenix's tripelennamine
hydrochloride injection is as a generic copy of Solvay's NADA 006-417
for Re-Covr Injection (tripelennamine hydrochloride). The
ANADA is approved as of March 28, 1996, and the regulations are amended
by revising Sec. 522.2615(b) (21 CFR 522.2615(b)) to reflect the
approval. The basis of approval is discussed in the freedom of
information summary. In addition, due to enactment of the Generic
Animal Drug and Patent Term Restoration Act of 1988, Sec. 522.2615(d)
is outdated and therefore removed.
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.
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 in 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 part 522 is
amended as follows:
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: Sec. 512 of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 360b).
Sec. 522.2615 [Amended]
2. Section 522.2615 Tripelennamine hydrochloride injection is
amended in
[[Page 29481]]
paragraph (b) by removing ``No. 053501'' and adding in its place ``Nos.
053501 and 059130'' and by removing paragraph (d).
Dated: May 28, 1996.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 96-14644 Filed 6-10-96; 8:45 am]
BILLING CODE 4160-01-F