[Federal Register Volume 61, Number 114 (Wednesday, June 12, 1996)]
[Rules and Regulations]
[Pages 29650-29651]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-14893]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
21 CFR Part 520
Oral Dosage Form New Animal Drugs; Praziquantel, Pyrantel
Pamoate, and Febantel Tablets
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
-----------------------------------------------------------------------
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 Bayer Corp., Agriculture Div., Animal
Health Products. The supplement provides for oral prescription use of
Drontal PlusTM for removal and control of the tapeworm
Echinococcus multilocularis in dogs.
EFFECTIVE DATE: June 12, 1996.
FOR FURTHER INFORMATION CONTACT: Sandra K. Woods, Center for Veterinary
Medicine (HFV-114), Food and Drug Administration, 7500 Standish Pl.,
Rockville, MD 20855, 301-594-0614.
SUPPLEMENTARY INFORMATION: Bayer Corp., Agriculture Div., Animal Health
Products, P.O. Box 390, Shawnee Mission, KS 66201, filed supplemental
NADA 141-007, which provides for oral prescription use of Drontal
PlusTM tablet for small dogs containing 22.7 milligrams (mg)
praziquantel, 22.7 mg pyrantel base (as pyrantel pamoate), and
[[Page 29651]]
113.4 mg febantel, and Drontal PlusTM tablet for medium and large
dogs containing 68 mg praziquantel, 68 mg pyrantel base (as pyrantel
pamoate), and 340.2 mg febantel. The supplement provides for use of the
tablet for removal and control of the cestode E. multilocularis in
dogs in addition to the previously approved use for removal of other
tapeworms (cestodes), hookworms, ascarids, and whipworms. Approval is
based on data and information in previously approved NADA's 111-607
(Droncit injectable solution) and 111-798 (Droncit tablets). The
supplement is approved as of March 28, 1996, and the regulations are
amended in Sec. 520.1872(c)(1)(ii) to reflect the approval. The basis
of approval is discussed in the freedom of information summary.
-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 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, from 9 a.m. to 4 p.m.,
Monday through Friday.
-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 supplemental approval
does not qualify for marketing exclusivity because no new clinical or
field investigations (other than bioequivalence studies), essential to
the approval, were conducted or sponsored by the applicant.
-The agency has determined under 21 CFR 25.24(d)(1)(i) 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 in 21 CFR Part 520
-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 520 is
amended as follows:
PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS
-1. The authority citation for 21 CFR part 520 continues to read as
follows:
-Authority: Sec. 512 of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 360b).
Sec. 520.1872 [Amended]
-2. Section 520.1872 Praziquantel, pyrantel pamoate, and febantel
tablets is amended in paragraph (c)(1)(ii) by adding the phrase ``and
for the removal and control of tapeworm Echinococcus multilocularis''
before the words ``in dogs''.
Dated: May 17, 1996.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 96-14893 Filed 6-11-96; 8:45 am]
BILLING CODE 4160-01-F
