Food and Drug Administration, HHS.
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 (NADAs) from Pfizer, Inc., to Schering-Plough Animal Health Corp.
This rule is effective July 31, 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: email@example.com.End Further Info End Preamble Start Supplemental Information
Pfizer, Inc., 235 East 42d St., New York, NY 10017, has informed FDA that it has transferred ownership of, and all rights and interest in, the following three approved NADAs to Schering-Plough Animal Health Corp., 1095 Morris Ave., Union, NJ 07083:
|NADA No.||Trade Name|
|55-069||ORBENIN DC (cloxacillin benzathine)|
|55-070||DARICLOX (cloxacillin sodium)|
|55-100||AMOXI-MAST (amoxicillin trihydrate)|
Accordingly, the agency is amending the regulations in 21 CFR 526.88, 526.464b, and 526.464c 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 526
- 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 526 is amended as follows:End Amendment Part Start Part
PART 526—INTRAMAMMARY DOSAGE FORMSEnd Part Start Amendment Part
1. The authority citation for 21 CFR part 526 continues to read as follows:End Amendment Part
2. Section 526.88 Amoxicillin trihydrate for intramammary infusion is amended in paragraph (b) by removing “000069” and by adding in its place “000061”.End Amendment Part
3. Section 526.464b Cloxacillin benzathine for intramammary infusion, sterile is amended in paragraph (d) by removing “000069” and by adding in its place “000061”.End Amendment Part
4. Section 526.464c Cloxacillin sodium for intramammary infusion, sterile is amended in paragraph (b) by removing “000069” and by adding in its place “000061”.End Amendment Part Start Signature
Dated: July 18, 2003.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary Medicine.
[FR Doc. 03-19445 Filed 7-30-03; 8:45 am]
BILLING CODE 4160-01-S