[Federal Register Volume 68, Number 181 (Thursday, September 18, 2003)]
[Rules and Regulations]
[Page 54658]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-23779]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 520


Oral Dosage Form 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 (NADAs) from Teva Pharmaceuticals USA to 
Delmarva Laboratories, Inc.

DATES:  This rule is effective September 18, 2003.

FOR FURTHER INFORMATION CONTACT:  David R. Newkirk, Center for 
Veterinary Medicine (HFV-100), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-827-6967, e-mail: 
[email protected].

SUPPLEMENTARY INFORMATION: Teva Pharmaceuticals USA, 650 Cathill Rd., 
Sellersville, PA 18960, has informed FDA that it has transferred 
ownership of, and all rights and interest in, the following two 
approved NADAs to Delmarva Laboratories, Inc., 1500 Huguenot Rd., suite 
106, Midlothian, VA 23113:

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        NADA No.                            Trade Name
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65-492                    ROBAMOX V (amoxicillin trihydrate) Tablets
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65-495                    ROBAMOX V (amoxicillin trihydrate)
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    Accordingly, the agency is amending the regulations in 21 CFR 
520.88b and 520.88f to reflect the transfer of ownership.
    This rule does not meet the definition of ``rule'' in 5 U.S.C. 
804(3)(A) because it is a rule of ``particular applicability.'' 
Therefore, it is not subject to the congressional review requirements 
in 5 U.S.C. 801-808.

List of Subjects in 21 CFR Part 520

    Animal drugs.

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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

0
1. The authority citation for 21 CFR part 520 continues to read as 
follows:

    Authority:  21 U.S.C. 360b.


Sec.  520.88b   [Amended]

0
2. Section 520.88b Amoxicillin trihydrate for oral suspension is 
amended in paragraph (c) by removing ``Sponsor. See Nos. 000093 and 
000856'' and by adding in its place ``Sponsors. See Nos. 000856 and 
059079''.


Sec.  520.88f   [Amended]

0
3. Section 520.88f Amoxicillin trihydrate tablets is amended in 
paragraph (b) by removing ``Sponsor. See Nos. 000093 and 000856'' and 
by adding in its place ``Sponsors. See Nos. 000856 and 059079''.

    Dated: August 28, 2003.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. 03-23779 Filed 9-17-03; 8:45 am]
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