CHORULON® APPROVED FOR ALL FISH

SUMMARY: The Food and Drug Administration (FDA) amended the animal drug regulations on August 6, 1999 to reflect approval of a supplemental new animal drug application (NADA # 140-927) filed by Intervet, Inc. (405 State Street, Millsboro, Delaware 19966-0318). The supplement provides for use of Chorulon® (chorionic gonadotropin) freeze-dried powder, reconstituted for intramuscular injection in male and female brood finfish as an aid in improving spawning function.

Conditions for use in finfish

(1) Amount. 50 to 510 I.U. per pound of body weight for males, 67 to 1816 I.U. per pound of body weight for females, by intramuscular injection.

(2) Indications for use. An aid in improving spawning function in male and female brood finfish.

(3) Limitations> May administer up to three doses. The total dose administered per fish (all injections combined) should not exceed 25,000 I.U. chorionic gonadotropin (25 milliliters) in fish intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Tolerances for residues of new animal drugs in food (Part 556.304)

(1) Acceptable daily intake (ADI). The ADI for residues of total gonadotropins (human chorionic gonadotropin and pregnant mare serum gonadotropin) is 42.25 I.U. per kilogram of body weight per day.

(2) Tolerances. A tolerance for residues of gonadotropin in uncooked edible tissues of cattle or of fish is not required.

 U.S. Food and Drug Administration. 1999. Implantation or injectable dosage form new animal drugs; chorionic gonadotropin. Code of Federal Regulations, 21 CFR Part 522.1081 and Part 556.304, September 7, 1999.

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