Food and Drug Administration, HHS.
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.
This rule is effective September 18, 2003.Start Further Info
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: firstname.lastname@example.org.End Further Info End Preamble Start Supplemental 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:
|NADA No.||Trade Name|
|65-492||ROBAMOX V (amoxicillin trihydrate) Tablets|
|65-495||ROBAMOX V (amoxicillin trihydrate)|
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.Start List of Subjects
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:End Amendment Part Start Part
PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGSEnd Part Start Amendment Part
1. The authority citation for 21 CFR part 520 continues to read as follows:End Amendment Part
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”.End Amendment Part
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”.End Amendment Part Start Signature
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]
BILLING CODE 4160-01-S