Document ID: FDA-2010-N-0002-0046
Agency: fda
Document Type: Notice
Title: Approval of a Supplemental New Animal Drug Application: Penicillin G Procaine Suspension
Posted Date: 2010-06-21T04:00Z

[Federal Register: June 21, 2010 (Volume 75, Number 118)]
[Notices]               
[Page 35044-35045]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr21jn10-95]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0002]

 
Notice of Approval of a Supplemental New Animal Drug Application; 
Penicillin G Procaine Suspension

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is providing notice 
that it has approved a supplemental new animal drug application (NADA) 
filed by Norbrook Laboratories, Ltd. The supplemental NADA provides for 
a revised formulation of penicillin G procaine injectable suspension 
that includes lecithin as a surfactant.

FOR FURTHER INFORMATION CONTACT: Cindy L. Burnsteel, Center for 
Veterinary Medicine (HFV-130), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 240-276-8341, e-mail: 
cindy.burnsteel@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Norbrook Laboratories, Ltd., Station Works, 
Newry BT35 6JP, Northern Ireland, filed a supplement to NADA 065-010 
for use of NOROCILLIN (penicillin G procaine) Injectable Suspension by 
intramuscular injection in cattle, sheep, swine, and horses. The 
supplement provides for a revised formulation that includes lecithin as 
a surfactant. In accordance with section 512(i) of the Federal Food, 
Drug, and Cosmetic Act (the act) (21 U.S.C. 360b(i)) and part 514 (21 
CFR 514), in Sec. Sec.  514.105(a) and 514.106(a), the Center for 
Veterinary Medicine is providing notice that this supplemental NADA is 
approved as of April 23, 2010.
    In accordance with the freedom of information provisions of 21 CFR 
part 20 and 21 CFR 514.11(e)(2)(ii), a summary of safety and 
effectiveness data and information submitted to support approval of 
this application may be seen in the Division of Dockets Management 
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852, between 9 a.m. and 4 p.m., Monday through Friday.
    Under section 512(c)(2)(F)(iii) of the act (21 U.S.C. 
360b(c)(2)(F)(iii)), this supplemental approval qualifies for 3 years 
of marketing exclusivity beginning on the date of approval.
    FDA has determined under 21 CFR 25.33 that this action is of a type 
that does not individually or cumulatively have a significant effect on 
the human environment. Therefore, neither an environmental assessment 
nor an environmental impact statement is required.

[[Page 35045]]

    Dated: June 15, 2010.
Elizabeth Rettie,
Deputy Director, Office of New Animal Drug Evaluation, Center for 
Veterinary Medicine.
[FR Doc. 2010-14865 Filed 6-18-10; 8:45 am]
BILLING CODE 4160-01-S