[Federal Register Volume 63, Number 214 (Thursday, November 5, 1998)]
[Rules and Regulations]
[Pages 59713-59714]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-29612]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 520
Oral Dosage Form New Animal Drugs; Sulfadimethoxine Soluble
Powder and Oral 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 two abbreviated new animal drug
applications (ANADA's) filed by Med-Pharmex, Inc. One ANADA provides
for the use of sulfadimethoxine soluble powder for use in drinking
water or as a drench, and the second ANADA provides for the use of the
oral solution in drinking water or as a drench, for the treatment of
chickens,
[[Page 59714]]
turkeys, and dairy calves, dairy heifers, and beef cattle.
EFFECTIVE DATE: November 5, 1998.
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: Med-Pharmex, Inc., 2727 Thompson Creek Rd,
Pomona, CA 91767-1861, has filed both ANADA 200-238 that provides for
the use of Sulfasol (sulfadimethoxine) soluble powder, and
ANADA 200-251 that provides for use of Sulforal
(sulfadimethoxine) concentrated solution, both for use in drinking
water or as a drench for the treatment of disease outbreaks as follows:
Coccidiosis, fowl cholera, and infectious coryza in chickens;
coccidiosis and fowl cholera in meat-producing turkeys; and shipping
fever complex and bacterial pneumonia associated with Pasteurella spp.
sensitive to sulfadimethoxine, and calf diphtheria and foot rot
associated with Sphaerophorus necrophorus sensitive to sulfadimethoxine
in dairy calves, dairy heifers, and beef cattle.
ANADA 200-238 is approved as a generic copy of Pfizer, Inc.'s NADA
46-285 for Albon (sulfadimethoxine soluble powder). ANADA
200-238 is approved as of July 28, 1998.
ANADA 200-251 is approved as a generic copy of Pfizer, Inc.'s NADA
31-205 for Albon (sulfadimethoxine 12.5% concentrated
solution). ANADA 200-251 is approved as of August 3, 1998.
Currently the regulations in Sec. 520.2220a (21 CFR 520.2220a) do
not specify which sponsors have approval for the oral solution or the
soluble powder. The section is amended to combine paragraphs (a) and
(b) to specify the approvals, including the new approvals. The basis
for approval is discussed in the freedom of information summaries.
In amending Sec. 520.2220a paragraph (a) is revised, paragraph (b)
is removed, and paragraphs (c) through (e) are redesignated as
paragraphs (b) through (d), respectively.
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 these
applications 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 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: 21 U.S.C. 360b.
2. Section 520.2220a is amended by revising paragraph (a), by
removing paragraph (b), and by redesignating paragraphs (c) through (e)
as paragraphs (b) through (d), respectively, to read as follows:
Sec. 520.2220a Sulfadimethoxine oral solution and soluble powder.
(a) Approvals. (1) For oral solution containing 12.5 percent (3.75
grams per ounce) sulfadimethoxine, see Nos. 000010, 000069, 051259,
057561, and 059130 in Sec. 510.600(c).
(2) For soluble powder, each package containing the equivalent of
94.6 grams of sulfadimethoxine (as the sodium salt), see Nos. 000069,
051259, and 057561 in Sec. 510.600(c).
* * * * *
Dated: October 22, 1998.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 98-29612 Filed 11-4-98; 8:45 am]
BILLING CODE 4160-01-F
