NATIONAL COORDINATOR

FOR AQUACULTURE NEW ANIMAL DRUG APPLICATIONS

Recent Approvals (OxyMarineÔ)

OxyMarineÔ APPROVED FOR ALL FINFISH

 SUMMARY:  The Food and Drug Administration (FDA) amended the animal drug regulations (i.e., Code of Federal Regulations) on January 30, 2004 to reflect the approval of a supplemental new animal drug application (NADA # 130-435) filed by Alpharma, Inc. (One Executive Drive, PO Box 1399, Fort Lee, New Jersey 07024).  The supplemental NADA was approved December 24, 2003.  The supplement provides for use of OXYMarineÔ (oxytetracycline hydrochloride soluble powder) for skeletal marking of finfish fry and fingerlings by immersion.

 Conditions for use in finfish

 (1)     Amount.  Immerse fish in a solution containing 200 to 700 mg oxytetracycline hydrochloride (buffered) per liter of water for 2 to 6 hours.

 (2)     Indications for use.  For skeletal marking of finfish fry and fingerlings.

Tolerances for residues of new animal drugs in food (Part 556.500)

 (1)     Acceptable daily intake (ADI).  The ADI for total tetracycline residues (chlortetracycline, oxytetracycline, and tetracycline) is 25 micrograms per kilogram of body weight per day.

 (2)     Tolerances.  A tolerance for the sum of residues of the tetracyclines including chlortetracycline, oxytetracycline, and tetracycline, in tissues for finfish and lobster is 2 parts per million (ppm) in muscle.

 U.S. Food and Drug Administration. 2004.  Certain other dosage form new animal drugs; oxytetracycline.  Code of Federal Regulations, 21 CFR Part 529.1660 and Part 556.500, February 11, 2004.