[Federal Register Volume 62, Number 147 (Thursday, July 31, 1997)]
[Rules and Regulations]
[Pages 40931-40932]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-20248]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 510 and 524
New Animal Drugs; Change of Sponsor
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is amending the animal
drug regulations to reflect a change of sponsor for three approved new
animal drug applications (NADA's) from Syntex Animal Health, Inc.,
Division of Syntex Agribusiness, Inc., to Medicis Dermatologics, Inc.
EFFECTIVE DATE: July 31, 1997.
FOR FURTHER INFORMATION CONTACT: Thomas J. McKay, Center for Veterinary
Medicine (HFV-102), Food and Drug Administration, 7500 Standish Pl.,
Rockville, MD 20855, 301-827-0213.
SUPPLEMENTARY INFORMATION: Syntex Animal Health, Inc., Division of
Syntex Agribusiness, Inc., 3401 Hillview Ave., P.O. Box 10850, Palo
Alto, CA 94303, has informed FDA that it has transferred ownership of,
and all rights and interests in NADA's 15-151 (fluocinolone acetonide,
neomycin sulfate cream), 15-152 (fluocinolone acetonide cream), and 15-
298 (fluocinolone acetonide solution) to Medicis Dermatologics, Inc.,
4343 East Camelback Rd., suite 250, Phoenix, AZ 85018-2700.
Accordingly, the agency is amending the regulations in 21 CFR 524.981a,
524.981b, and 524.981c to reflect the transfer of ownership. The agency
is also amending the regulations in 21 CFR 510.600(c)(1) and (c)(2) by
alphabetically adding a new listing for Medicis Dermatologics, Inc.
List of Subjects
21 CFR Part 510
Administrative practice and procedure, Animal drugs, Labeling,
Reporting and recordkeeping requirements.
21 CFR Part 524
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 parts 510 and
524 are amended as follows:
PART 510--NEW ANIMAL DRUGS
1. The authority citation for 21 CFR part 510 continues to read as
follows:
Authority: Secs. 201, 301, 501, 502, 503, 512, 701, 721 of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321, 331, 351, 352,
353, 360b, 371, 379e).
2. Section 510.600 is amended in the table in paragraph (c)(1) by
alphabetically adding a new entry for ``Medicis Dermatologics, Inc.''
and in the table in paragraph (c)(2) by numerically adding a new entry
for ``099207'' to read as follows:
Sec. 510.600 Names, addresses, and drug labeler codes of sponsors of
approved applications.
* * * * *
(c) * * *
(1) * * *
------------------------------------------------------------------------
Firm name and address Drug labeler code
------------------------------------------------------------------------
* * * *
* * *
Medicis Dermatologics, Inc., 4343 East 099207
Camelback Rd., suite 250, Phoenix, AZ
85018-2700.
* * * *
* * *
------------------------------------------------------------------------
(2) * * *
[[Page 40932]]
------------------------------------------------------------------------
Drug labeler code Firm Name and address
------------------------------------------------------------------------
* * * *
* * *
099207................................... Medicis Dermatologics, Inc.,
4343 East Camelback Rd.,
suite 250, Phoenix, AZ 85018-
2700.
* * * *
* * *
------------------------------------------------------------------------
PART 524--OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS
3. The authority citation for 21 CFR part 524 continues to read as
follows:
Authority: Sec. 512 of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 360b).
Sec. 524.981a [Amended]
4. Section 524.981a Fluocinolone acetonide cream is amended in
paragraph (b) by removing ``000033'' and adding in its place
``099207''.
Sec. 524.981b [Amended]
5. Section 524.981b Fluocinolone acetonide solution is amended in
paragraph (b) by removing ``000033'' and adding in its place
``099207''.
Sec. 524.981c [Amended]
6. Section 524.981c Fluocinolone acetonide, neomycin sulfate cream
is amended in paragraph (b) by removing ``000033'' and adding in its
place ``099207''.
Dated: July 23, 1997.
Robert C. Livingston,
Director, Office of New Animal Drug Evaluation, Center for Veterinary
Medicine.
[FR Doc. 97-20248 Filed 7-30-97; 8:45 am]
BILLING CODE 4160-01-F
