Summary of 
FDA Information:
FOI Summary; NADA 200-134 (original); Fertagyl ® (gonadorelin diacetate tetrahydrate); June 17, 1996
--Editor's abstract
1. GENERAL INFORMATION:

ANADA: 200-134

ANADA/GENERIC SPONSOR:

  

Intervet Inc.
405 State Street
P.O. Box 318
Millsboro, DE 19966-0318 
 

a.Established Name: gonadorelin diacetate tetrahydrate injection 
b.Trade/Proprietary Name: Fertagyl ® 

c.Dosage Form: sterile injectable solution 

d.How Supplied: 2mL and 
20 mL vials 

e.How Dispensed:Rx

f.Amount of 
Active Ingredient: 43 mcg/mL gonadorelin equivalent to 50 mcg/mL gonadorelin diacetate tetrahydrate 

g.Route of 
Administration: Intramuscular or 
intravenous in cattle 

h.Species: Dairy cattle (females of 
breeding age) 

i. Pioneer Product/"Listed" Product: Cystorelin®, NADA 098-379, Sanofi Animal Health 

Date of 
Approval: June 17, 1996

2. INDICATIONS 

Fertagyl ® is indicated for 
the treatment of 
ovarian follicular cysts in dairy cattle. Ovarian cysts are non-ovulated follicles with incomplete luteinization which 
result in nymphomania or 
irregular estrus.

Historically, cystic ovaries have responded to an exogenous source of 
luteinizing hormone (LH) such as human chorionic gonadotropin. Fertagyl ® initiates release of 
endogenous LH to cause ovulation and 
luteinization. 

3. DOSAGE 

CATTLE 

The recommended intramuscular or 
intravenous dosage of 
Fertagyl ® is 2 mL/cow, containing 86 mcg gonadorelin (equivalent to 100 mcg gonadorelin diacetate tetrahydrate). 

4. TARGET ANIMAL SAFETY and 
DRUG EFFECTIVENESS:

Under the provisions of 
the Federal Food, Drug, and 

Cosmetic Act, as amended by the Generic Animal Drug and 
Patent Term Restoration Act, (53 FR 50460, December 15, 1988, First GADPTRA Policy Letter) an abbreviated 
new animal drug application (ANADA) may be submitted for 
a generic version of 
an approved new animal drug (pioneer product). New target animal safety data, drug effectiveness data, and 

human food safety data (other than tissue residue data) are not required for 
approval of an ANADA. An ANADA relies on the target animal safety, drug effectiveness, and 

human food safety data in the 
pioneer's new animal drug application. Ordinarily, the 
ANADA sponsor shows that the 
generic product is bioequivalent to the pioneer. If bioequivalence is demonstrated through a clinical end-point study 
, then a tissue residue study 
to establish the withdrawal time for 
the generic product is also required. For certain dosage forms, the 
agency will grant a waiver from 
conducting an in vivo bioequivalence study 
(55 FR 24645, June 18, 1990; Fifth GADPTRA Policy Letter; Bioequivalence Guideline, April 1990).

Based upon the formulation characteristics of 
the generic product, Intervet Inc. was 
granted a waiver from 
conducting an in vivo bioequivalence study 
for gonadorelin diacetate tetrahydrate.
The generic and 
pioneer products contain the same active and 
inactive ingredients and 
are parenteral solutions. 

5. HUMAN FOOD SAFETY:

Tolerance

A tolerance has not been established for 
gonadorelin diacetate tetrahydrate.

Withdrawal Time

When a waiver of 
in vivo bioequivalence testing is granted, the 
withdrawal times are those previously assigned to the pioneer product.
A zero withdrawal is applied to gonadorelin diacetate tetrahydrate.

Regulatory Method for 
Residues

Since gonadorelin is approved with a zero withdrawal, an official analytic method is not needed. 

6. AGENCY CONCLUSIONS: 

This ANADA submitted under 
section 512(b) of 
the Federal Food, Drug, and 

Cosmetic Act satisfies the requirements of 
section 512(n) of 
the act and 
demonstrates that gonadorelin diacetate tetrahydrate injection when 
used under 
the proposed conditions of 
use, is safe and 
effective for 
its labeled indications.

Attachments: 

The following generic labeling and 
currently approved pioneer labeling are attached.

Facsimile bottle label and 
insert for 
generic gonadorelin diacetate tetrahydrate - Fertagyl ® , gonadorelin 43 mcg/mL, equivalent to 50 mcg/mL gonadorelin diacetate tetrahydrate in 2 mL (single dose) and 
20 mL (multiple dose) vials

Approved pioneer vial label and 
insert for 
gonadorelin diacetate tetrahydrate - Cystorelin ® , gonadorelin diacetate tetrahydrate 50 mcg/mL, 2 mL and 
10 mL vials. 

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 



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