Approval Date: November 22, 1991
I. GENERAL INFORMATION:
Intervet America, Inc.
P. O. Box 318
405 State Street
Millsboro, DE 19966
II. INDICATIONS FOR USE
CHORULON is indicated for the intramuscular use in cows for the treatment of nymphomania (frequent or constant heat) due to cystic ovaries.
III. DOSAGE FORM(S), ROUTE OF ADMINISTRATION AND RECOMMENDED DOSAGE
CHORULON is supplied in cartons containing five single dose vials of freeze-dried powder, plus five 10 mL vials of sterile diluent. When reconstituted, each single dose vial (10 mL) contains 10,000 I.U. chorionic gonadotropin (equivalent to 10,000 U.S.P. Units chorionic gonadotropin) in phosphate-buffered water for injection.
One dose (10 mL) of reconstituted CHORULON should be administered as a single deep intramuscular injection. Dosage may be repeated in 14 days if the animal's behavior or rectal examination of the ovaries indicates the necessity for retreatment.
The approval of the new animal drug application for chorionic gonadotropin for injection is based on the NAS/NRC (DESI) efficacy review published in the Federal Register of December 6, 1969 (34 Fed. Reg. 19388). The Food and Drug Administration concurred with the Academy's conclusion (id.), and subsequently approved a supplemental new animal drug application (NADA) for the DESI-reviewed pioneer product (37 Fed. Reg. 4333; March 2, 1972). U.S.P. bioassay results submitted by the sponsor demonstrate biological equivalence to the pioneer product.
V. ANIMAL SAFETY
The NADA for the DESI-reviewed pioneer product was originally approved as safe for use as labeled on December 19, 1946. FDA reaffirmed that conclusion on March 2, 1972 (37 Fed. Reg. 4333) when it approved the supplemental application for that product. NADA 140- 927 is approved via demonstration of equivalence to the pioneer product. Therefore, no additional target animal safety studies were required.
VI. HUMAN FOOD SAFETY:
a) Toxicity studies:
Human chorionic gonadotropin is not orally active; therefore, residues of chorionic gonadotropin are safe for human consumption, and toxicological studies were not required.
b) Residue studies:
As there was no requirement for toxicological testing, tissue residue studies were not required and there is no tolerance, withdrawal period, or regulatory method for CHORULON (human chorionic gonadotropin).
VII. AGENCY CONCLUSIONS:
The data submitted in support of this NADA satisfy the requirements of section 512 of the Act and demonstrate that CHORULON (chorionic gonadotropin), when used under its labeled conditions of use, is safe and effective for intramuscular use in cows for the treatment of nymphomania (frequent or constant heat) due to cystic ovaries.
The sponsor submitted U.S.P. bioassay results which demonstrate biological equivalence to the pioneer product.
Chorionic Gonadotropin injection for use in food-producing animals is currently on the market as a prescription drug. Accurate diagnosis can only be made, and the conditions for use prescribed on the labeling can only be followed, by a licensed veterinarian. Therefore, this product, like the pioneer, is a prescription drug.
Under the Generic Animal Drug and Patent Term Restoration Act of 1988, this approval does not qualify for an exclusivity period under section 512(c)(2)(F) of the Federal, Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360b (c)(2)(F) because the active ingredient in this product has been approved under section 512(b) of the act for the same indication at the same dose in another NADA.
VIII. LABELING (Attached)
Copies of applicable labels may be obtained by writing to the:
Freedom of Information Office
Center for Veterinary Medicine, FDA
7500 Standish Place
Rockville, MD 20855