[Federal Register Volume 63, Number 31 (Tuesday, February 17, 1998)]
[Rules and Regulations]
[Pages 7700-7701]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-3902]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 510 and 522
New Animal Drugs; Change of Sponsor
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 a change of sponsor for two approved new
animal drug applications (NADA's) from DuPont Merck Pharmaceutical Co.
to Endo Pharmaceuticals, Inc.
EFFECTIVE DATE: February 17, 1998.
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: DuPont Merck Pharmaceutical Co., DuPont
Merck Plaza, MR2117, Wilmington, DE 19805, has informed FDA that it has
transferred ownership of, and all rights and interests in NADA 30-525
(Oxymorphone hydrochloride) and NADA 35-825 (Naloxone hydrochloride),
to Endo Pharmaceuticals, Inc., 223 Wilmington West Chester Pike, Chadds
Ford, PA 19317. Accordingly, the agency is amending the regulations in
21 CFR 522.1462 and 522.1642 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 Endo Pharmaceuticals,
Inc.
List of Subjects
21 CFR Part 510
Administrative practice and procedure, Animal drugs, Labeling,
Reporting and recordkeeping requirements.
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 parts 510 and
522 are amended as follows:
PART 510--NEW ANIMAL DRUGS
1. The authority citation for 21 CFR part 510 continues to read as
follows:
Authority: 21 U.S.C. 321, 331, 351, 352, 353, 360b, 371, 376e.
2. Section 510.600 is amended in paragraph (c)(1) by alphabetically
adding a new entry for ``Endo Pharmaceuticals, Inc.'' and in the table
in paragraph (c)(2) by numerically adding a new entry for ``060951'' to
read as follows:
Sec. 510.600 Names, addresses, and drug labeler codes of sponsors of
approved applications.
* * * * *
(c) * * *
(1) * * *
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Firm name and address Drug labeler code
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* * * * * *
*
Endo Pharmaceuticals, Inc., 223 Wilmington West
Chester Pike, Chadds Ford, PA 19317 060951
* * * * * *
*
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(2) * * *
[[Page 7701]]
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Drug labeler code Firm Name and address
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* * * * * *
*
060951 Endo Pharmaceuticals, Inc., 223 Wilmington West
Chester Pike, Chadds Ford, PA 19317.
* * * * * *
*
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PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS
3. The authority citation for 21 CFR part 522 continues to read as
follows:
Authority: 21 U.S.C. 360b.
Sec. 522.1462 [Amended]
4. Section 522.1462 Naloxone hydrochloride injection is amended in
paragraph (b) by removing ``000056'' and adding in its place
``060951''.
Sec. 522.1642 [Amended]
5. Section 522.1642 Oxymorphone hydrochloride injection is amended
in paragraph (b) by removing ``000056'' and adding in its place
``060951''.
Dated: January 28, 1998.
Andrew J. Beaulieau,
Acting Director, Office of New Animal Drug Evaluation, Center for
Veterinary Medicine.
[FR Doc. 98-3902 Filed 2-13-98; 8:45 am]
BILLING CODE 4160-01-F
