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U.S. Department of Health and Human Services

Animal & Veterinary

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NADA 141-007 Drontal™ Plus Broad Spectrum Anthelmintic Tablets - supplemental approval (March 28, 1996)

Approval Date: March 28, 1996

I. GENERAL INFORMATION

NADA141-007
Sponsor:Bayer Corporation
Agriculture Division
Animal Health Products
P.O. Box 390
Shawnee Mission, Kansas 66201
Generic Name:Praziquantel + Pyrantel Pamoate + Febantel
Trade Name:Drontal™ Plus Broad Spectrum Anthelmintic Tablets
Marketing Status:Prescription
Effect of Supplement:This supplemental application amends NADA 141-007, Drontal™ Plus Broad Spectrum Anthelmintic Tablets, by adding the tape-worm Echinococcus multilocularis claim to the label.

 

II. INDICATIONS FOR USE

Tapeworms (Dipylidium caninum, Taenia pisiformis, Echinococcus granulosus, and Echinococcus multilocularis), hookworms (Ancylostoma caninum and Uncinaria stenocephala), ascarids (Toxocara canis and Toxascaris leonina), and whipworms (Trichuris vulpis).

 

III. DOSAGE FORM(S), ROUTE OF ADMINISTRATION AND RECOMMENDED DOSAGE

Drontal(TM) Plus (praziquantel/pyrantel pamoate/febantel) Broad Spectrum Anthelmintic Tablets are available in two sizes. Each size is scored for convenient oral administration.

Each Drontal(TM) Plus Tablet for Medium and Large Dogs contains 68.0 mg praziquantel, 68.0 mg pyrantel base as pyrantel pamoate and 340.2 mg febantel.

Each Drontal(TM) Plus Tablet for Small Dogs contains 22.7 mg praziquantel, 22.7 mg pyrantel base as pyrantel pamoate and 113.4 mg febantel.

DOSAGE CHARTS

Drontal(TM) Plus Tablets for Small Dogs*(2-25 lbs.)

Body Wt. (lbs.)Number of Tablets
2 - 4 0.5
5 - 7 1.0
8 - 121.5
13 - 18       2.0
19 - 25        2.5

 

Drontal(TM) Plus Tablets for Medium & Large Dogs (26 lbs. and over)

Body Wt. (lbs.)Number of Tablets
26 -  30       1.0 
31 - 441.5
45 - 602.0
61 - 742.5
75 - 903.0
91 - 1043.5
105 - 1204.0

*NOT FOR USE IN DOGS WEIGHING LESS THAN 2 LBS. OR PUPPIES LESS THAN 3 WEEKS OF AGE. Tablets may be given directly by mouth or offered in a small amount of food. Fasting is neither necessary nor recommended prior to or after treatment.

 

IV. EFFECTIVENESS

Efficacy of Drontal(TM) Plus (praziquantel/pyrantel pamoate/febantel) Broad Spectrum Anthelmintic Tablets [59 FR 33908, July 1, 1994] against E. multilocularis in dogs is based on the scientific data described in the Freedom of Information (FOI) Summary for Droncit (praziquantel). Tablets [NADA 111-798, 58 FR 42852-3, Aug. 12, 1993].

Echinococcus granulosus and Echinococcus multilocularis are classified in the same genus. The laboratory data described in the FOI Summary of NADA 111-798 indicate that Droncit (praziquantel) Tablets [NADA 111-798, 58 FR 42852-3, Aug. 12, 1993] is 100% efficacious against both E. granulosus and E. multilocularis. The FOI Summary for the three-way combination Drontal(TM) Plus (praziquantel/pyrantel pamoate/febantel) Broad Spectrum Anthelmintic Tablets (59 FR 33908, July 1, 1994] states that neither pyrantel nor febantel interfered with the activity of praziquantel against E. granulosus.

Since E. granulosus and E. multilocularis are classified in the same genus, Droncit (praziquantel) Tablets [NADA 111-798, 58 FR 42852-3, Aug. 12, 1993] demonstrated 100% efficacy against both E. granulosus and E. multilocularis in laboratory studies, and no interference was demonstrated in the three-way combination product, it is concluded that praziquantel in Drontal(TM) Plus (praziquantel/pyrantel pamoate/febantel) Broad Spectrum Anthelmintic Tablet is as efficacious as the Droncit (praziquantel) Tablet against E. multilocularis.

 

V. ANIMAL SAFETY

Animal safety is cross referenced to the existing, orginal Freedom of Information Summary for Drontal(TM) Plus (praziquantel/pyrantel pamoate/febantel) Broad Spectrum Anthelmintic Tablets (59 FR 33908, July 1, 1994] . The original FOI Summary describes the safety studies that were conducted to support the approval of this product.

 

VI. HUMAN SAFETY

Human safety is cross referenced to the existing, original Freedom of Information Summary for Drontal(TM) Plus (praziquantel/pyrantel pamoate/febantel) Broad Spectrum Anthelmintic Tablets (59 FR 33908, July 1,1994].

 

VII. AGENCY CONCLUSIONS

The data in support of this supplemental New Animal Drug Application complies with the requirements of Section 512 of the Act and Section 514.111 of the implementing regulations. When used under the labeled conditions of use, the data demonstrates that Drontal(TM) Plus (praziquantel/pyrantel pamoate/febantel) Broad Spectrum Anthelmintic Tablets (59 FR 33908, July 1, 1994] are safe and effective in the treatment of dogs with Echinococcus multilocularis.

Since the approval of this supplement utilized studies conducted with another formulation of praziquantel [Droncit (praziquantel) Tablets, NADA 111-798, 58 FR 42852-3, Aug. 12, 1993], the addition of E. multilocularis as a claim on the label does not extend the original exclusivity period for Drontal(TM) Plus (praziquantel/pyrantel pamoate/febantel) Broad Spectrum Anthlmintic Tablets which began May 19, 1994 (59 FR 33908, July 1, 1994].

 

VIII. LABELING (Attached)

  1. Facsimile labeling.
    • Bottle label for 22.7 mg tablet.
    • Bottle label for 68.0 mg tablet.
    • Package insert for 22.7 and 68.0 mg tablets.

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

Freedom of Information Office
Center for Veterinary Medicine, FDA
7500 Standish Place
Rockville, MD 20855