[Federal Register Volume 64, Number 62 (Thursday, April 1, 1999)]
[Rules and Regulations]
[Page 15685]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-7922]
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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;
Dinoprost Tromethamine Sterile Solution
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 intramuscular use of dinoprost tromethamine sterile
solution in cattle, swine, and mares.
EFFECTIVE DATE: April 1, 1999
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: Phoenix Scientific, Inc., 3915 South 48th
St. Terrace, P.O. Box 6457, St. Joseph, MO 64506-0457, filed ANADA 200-
253 that provides for use of ProstaMateTM (dinoprost
tromethamine injection) for intramuscular, veterinary prescription use
for estrus synchronization, treatment of unobserved (silent) estrus and
pyometra (chronic endometritis) in cattle; for abortion of feedlot and
other nonlactating cattle; for parturition induction in swine; and for
controlling the timing of estrus in estrous cycling mares and
clinically anestrous mares that have a corpus luteum.
Approval of Phoenix's ANADA 200-253 for ProstaMateTM
(dinoprost tromethamine injection) sterile solution is as a generic
copy of Pharmacia & Upjohn's NADA 108-901 Lutalyse (dinoprost
tromethamine) sterile solution. ANADA 200-253 is approved as of
February 12, 1999, and the regulations are amended in 21 CFR 522.690(b)
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 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, 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(a)(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 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: 21 U.S.C. 360b.
Sec. 522.690 [Amended]
2. Section 522.690 Dinoprost tromethamine sterile solution is
amended in paragraph (b) by removing ``No. 000009'' and adding in its
place ``Nos. 000009 and 059130''.
Dated: March 18, 1999.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 99-7922 Filed 3-31-99; 8:45 am]
BILLING CODE 4160-01-F
