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U.S. Department of Health and Human Services

Animal & Veterinary

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NADA 039-077 CSP(TM) 250 and CSP(TM) 500 - supplemental approval (December 11, 1995)

I. GENERAL INFORMATION:

NADA039-077
Sponsor:Fermenta Animal Health Company
Elwood, KS 66024
Generic Name:chlortetracyline (as hydrochloride), sulfathiazole, penicillin (as procaine penicillin)
Trade Name:CSP(TM) 250 and CSP(TM) 500
Marketing Status:Over the Counter (OTC)
Effect of Supplement:The supplemental NADA provides for revised Type A medicated article, and Type B and C medicated feed labeling. CSP(TM) can be used from 10 pounds body weight up to 6 weeks post-weaning.

II. INDICATIONS FOR USE

Pre-Starter and Starter Feeds:

Administer to swine in a complete feed for reduction of the incidence of cervical abscesses; treatment of bacterial enteritis (salmonellosis or necrotic enteritis caused by Salmonella choleraesuis and vibrionic dysentery); maintenance of weight gains in the presence of atrophic rhinitis; increased rate of weight gain and improved feed efficiency from 10 pounds body weight up to 6 weeks post-weaning. For swine raised in confinement (drylot) or on limited pasture.

Grower and Finisher Feeds:

Administer to swine in a complete feed for reduction of the incidence of cervical abscesses; treatment of bacterial enteritis (salmonellosis or necrotic enteritis caused by Salmonella choleraesuis and vibrionic dysentery); maintenance of weight gains in the presence of atrophic rhinitis; increased rate of weight gain from 6 to 16 weeks post-weaning. For swine raised in confinement (drylot) or on limited pasture.

III. DOSAGE:

A.DOSAGE FORM

This NADA provided for the use of the approved Type A medicated articles, CSP (TM) 250 and CSP (TM) 500, as per 21 CFR § 558.155, to make Type B medicated feeds and Type C medicated feeds. CSP (TM) 250 is supplied as Type A medicated articles in 5, 10 and 50-lb bags. CSP (TM) 500 is supplied as Type A medicated articles in 5 and 50-lb bags.

B.ROUTE OF ADMINISTRATIONOrally, in the feed.
C.RECOMMENDED DOSAGES:

 

The recommended dosage of chlortetracycline, sulfathiazole and penicillin is 100, 100, and 50 grams per ton in combination in Type C medicated feeds for swine.

 NOTES 

IV. & V. EFFECTIVENESS AND ANIMAL SAFETY:

The supplemental NADA provides for revised Type A medicated article, and Type B and C medicated feed labeling. Changes in the approved labeling are required to bring the labeling in concert with existing management practices, i.e., lower weaning weights. Although the previous label indicates use in 20 pound pigs, the data in the NADA support the safety and effectiveness of CSP(TM) from 10 pounds body weight up to 6 weeks post-weaning. Changes to the label include "for use in pigs from 10 pounds body weight up to 6 weeks post-weaning," and deletion of the "Minimum Desired Daily Feed Intake" table in the "Caution" statement. The "Permitted Claims and Limitation" and "Caution" sections of the labeling reflect these changes.

The "Minimum Desired Daily Feed Intake" table is removed because the enhanced performance or therapeutic benefits of CSP(TM) is based on ad libitum consumption, and not the minimum desired daily feed intake consumption values reported in the table. Therefore, these consumption values may be misleading if these desired daily feed intake consumption values are obtained and the desired performance does not result. This together with changes in weaning weights renders the "Minimum Desired Daily Feed Intake" table obsolete.

Additional effectiveness studies were not required because the data from studies contained in the NADA indicate that CSP(TM) is effective when used in swine feeds in accordance with the revised label. For performance claims, the starting weights of pigs used in the original studies ranged from ~ 13 to ~ 20 pounds. For therapeutic claims, the pathology of the labeled diseases are similar between 10 pound pigs and the pigs used to demonstrate the therapeutic effectiveness in the NADA. No scientific evidence could be established that would indicate differences in drug metabolism for CSP(TM) between 10 pound pigs and pigs used to demonstrate therapeutic or production claims. Differences in immune competency and differences in digestive enzyme production should not affect the effectiveness or metabolism of CSP(TM) in 10 pound pigs for the labeled claims. Therefore, the effectiveness data contained in the NADA supports the approval of this supplemental NADA for the use of CSP(TM) in from 10 pounds body weight up to 6 weeks post-weaning.

An additional safety study was not required because adequate data has been provided to show that these compounds are compatible in combination when used in swine feeds. The target animal safety data in the NADA is adequate to support this supplemental NADA. The starting weight of the pigs used in the target animal safety study ranged between 13 and 24 pounds. No scientific evidence could be established that would indicate differences in drug metabolism for CSP(TM) between 10 pound pigs and 13 to 20 pound pigs. Differences in immune competency and differences in digestive enzyme production between 10 and 13 pound pigs should not affect the safety or metabolism of CSP(TM) in 10 pound pigs. The target animal safety study demonstrates that no ill effects occurred when these drugs were fed in combination. Therefore, based on the data in the NADA, it is concluded that these drugs may be effectively and safely fed to swine, as indicated on the labeling.

VI. HUMAN SAFETY:

VII. AGENCY CONCLUSIONS:

The data submitted in support of this NADA comply with the requirements of Section 512 of the Act and demonstrate that CSP (TM) 250 and CSP (TM) 500 are safe and effective for the claims indicated in Section II of this FOI summary.

Pursuant to 21 CFR § 514.106 (b)(2), this supplemental NADA approval is regarded as a Category II supplemental change which did not require a reevaluation of safety and effectiveness data. These drugs are to be fed in Type B and Type C medicated feeds, in accordance with Sections II and III of the FOI Summary and the Type A medicated article and Blue Bird labeling that is attached to this document.

Under section 512(c)(2)(F)(iii) of the Federal Food, Drug and Cosmetic Act, this approval for food producing animals does not qualify for marketing exclusivity because the supplemental application does not contain new clinical or field investigations (other than bioequivalence or residue studies) and new human food safety studies (other than bioequivalence or residue studies) essential to the approval and conducted or sponsored by the applicant.

VIII. LABELING (Attached)

  1. FERMENTA(TM) ANIMAL HEALTH CSP(TM) 500 front panel package label
  2. FERMENTA(TM) ANIMAL HEALTH CSP(TM) 500 back panel package label
  3. Type C Medicated Swine Feed, Complete Swine Ration product label

Copies of applicable labels may be obtained by writing to the:

Food and Drug Administration
Freedom of Information Staff (HFI-35)
5600 Fishers Lane
Rockville, MD 20857

Or requests may be sent via fax to: (301) 443-1726. If there are problems sending a fax, call (301) 443-2414.