National Coordinator For Aquaculture New Animal Drug Applications |
The objectives for the second year of the project were to:
The National NADA Coordinator's position was increased to full time during the second year. The National NADA Coordinator worked to obtain INADs, NADA approvals, and sponsors for drugs that are considered to be high priority for approval by the public and private aquaculture community in the United States.
Amoxicillin: Two sponsors submitted INAD/NADA letters of intent. Two foreign sponsors, Vetrepharm of the United Kingdom and Gurvey and Berry Co. Inc. of Canada, have INAD exemptions, and one sponsor's INAD is active on controlling streptococcal infections in tilapia and hybrid striped bass. Species that are under consideration for study include catfish, salmonids, hybrid striped bass, tilapia, walleye, and yellow perch.
Chloramine-T: Akzo Nobel Chemicals, Inc. committed to the drug's approval and will submit an INAD letter of intent. The company indicated it will fund the mutagenicity studies required by CVM. Several compassionate INADs are held by public aquaculture agencies and organizations. The International Association of Fish and Wildlife Agencies project (IAFWA Project) at the Upper Mississippi Science Center (UMSC) is developing target animal safety, efficacy, analytical methods in water and fish tissue, residue/metabolism data and the environmental assessment.
Erythromycin: The University of Idaho submitted all required NADA data to CVM. Several pharmaceutical and chemical companies in the U.S. and United Kingdom are interested in sponsoring the drug for the prevention and control of bacterial kidney disease in salmonids. There is interest in developing the drug to control streptococcal infections in tilapia and hybrid striped bass.
Florfenicol: Canada is close to approving this oral antibacterial for use in salmonids. U.S. approval is being pursued through the U.S.-Canadian Harmonization of Aquaculture Drug Approvals and the potential U.S. sponsor, Schering-Plough Animal Health. The University of Arizona has an INAD for development of the drug in penaeid shrimp.
Oxytetracycline (OTC): The compound is approved for control of certain bacterial diseases in catfish, salmonids, and lobsters. CVM will continue INADs for use of OTC as a marking agent but indicated the agency is close to a decision in extending the NADA for that purpose to all cultured freshwater fish. the coordiantor met with CVM in April 1997 to discuss remaining data requirements to obtain full approval for OTC. Efficacy data from two compassionate INAD projects has undergone preliminary review, and an effort has been made to develop quality data criteria that will help the review process for gaining revised labels for OTC and to develop new NADAs for other drugs.
Sarafloxacin: Abbott Laboratories is completing a technical section of data requirements for NADA approval. The National NADA Coordinator met with Abbott in February 1997 to discuss completion of the data requirements and a strategy for risk assessment. The catfish industry, researchers, and the U.S. Department of Agriculture agreed to consider developing a risk assessment on the use of sarafloxacin in catfish to control enteric septicemia to alleviate concerns of disease resistance developing in humans from the use of this fluoroquinolone in catfish.
Formalin: CVM accepted data that will lead to expansions of the formalin NADA. Current U.S. sponsors Western Chemical Co., Argent Chemical Laboratories, and Natchez Animal Supply were asked to amend their NADAs to include the control of certain fungi on the eggs of all finfish and certain external protozoa and monogenetic trematodes on all finfish. INAD holders have been invited to submit data that has been generated to extend the NADA for the control or prevention of mortalities associated with saprolegniasis on all cultured freshwater fish.
Copper Sulfate: One U.S. sponsor, Phelps Dodge Refining Corporation, applied for an INAD/NADA after encouragement by the National NADA Coordinator. Two meetings were held in July and August 1996 to discuss the development of the Phelps Dodge product. The human food and environmental safety requirements have been met. The Stuttgart National Aquaculture Research Center (SNARC) is preparing the efficacy and target animal safety NADA technical sections.
Cutrine-Plus: The pesticide registrant and potential U.S. sponsor, Applied Biochemists, Inc., indicated an interest in pursuing an INAD/NADA and was sent a sample draft letter of intent on May 16, 1997. Efficacy data have been generated by the State of Iowa. EarthTec: Earth Science Laboratories, Inc., the U. S. pesticide registrant of EarthTec, recently submitted an INAD/NADA application and is actively pursuing the development of data. Several facilities are interested in developing efficacy data.
Hydrogen Peroxide: CVM declared this a Low Regulatory Priority (LRP) drug as a fungicide on fish and their eggs. A U.S. sponsor, Eka Nobel Inc., received an INAD for its use as a fungicide on fish eggs in the U.S. The compound is near approval in Canada. Efforts are underway to use the U.S.-Canada Harmonization on Aquaculture Drug Approvals to gain U.S. approval of the drug for the same use. UMSC developed efficacy and target animal safety data on its use to control or prevent mortalities associated with saprolegniasis on fish eggs and is developing pivotal efficacy and target animal safety data for its use to control or prevent mortalities associated with saprolegniasis on freshwater fish. UMSC is assessing its use to control or prevent mortalities associated with external flavobacterial infections and its use to control or prevent external parasitic infestations on cultured freshwater fish.
Quinine: The potential sponsor, Tetra, a division of Warner Lambert of Germany, expressed interest in pursuing an INAD/NADA for this drug in the U.S. and was sent a sample draft letter of intent on March 27, 1997. Research has shown that the drug given to fish in feed has the potential to control external protozoans and microsporidiosis (e.g., whirling disease).
Fumagillin, a compound for microsporidiosis control: The potential sponsor, Sanofi Sante Nutrition Animale of France, expressed interest in developing an INAD/NADA. Several researchers are determining the drug's potential to control or prevent hamburger gill disease in catfish and whirling and proliferative kidney diseases in salmonids.
Praziquantel, a compound for trematode and cestode control: The potential sponsor, Bayer AG of Germany, expressed interest in pursuing an INAD/NADA for this drug in the U.S. A sample draft letter of intent was sent to Bayer AG on March 27, 1997.
Trichlorfon, an external parasite control: The potential sponsor, Bayer AG, expressed interest in pursuing an INAD/NADA for this drug in the U.S. A sample draft letter of intent was sent to Bayer AG on March 27, 1997.
Salmosan: This compound, considered a pesticide in Canada, is nearing registration there. The U.S. considers it a drug and the potential sponsor, Novartis Animal Health, is considering an INAD/NADA for its use on salmon. A sample draft letter of intent was sent to Novartis on April 1, 1997.
Pet Fish Therapeutants (various drugs and pesticides): The coordinator met with CVM to discuss how to meet the requirements of NADAs for the pet fish industry using literature, packaging, and labeling to met the data and human food safety concerns for a potential diversion to the food fish industry.
Aqui-S: Aqui-S New Zealand Ltd. is pursuing approval of this potential zero withdrawal time anesthetic worldwide and has proceeded with several research projects. Aqui-S is already approved in New Zealand.
Benzocaine: Under the IAFWA Project, UMSC has completed several residue chemistry studies on benzocaine and will continue with the remaining technical sections if benzocaine is selected as the candidate anesthetic.
Common Carp Pituitary (CCP): Stoller Fisheries became an INAD/NADA sponsor in 1996. The National Aquaculture Association is providing funding for target animal safety studies at Auburn University. The U.S. Fish and Wildlife Service (FWS) in completing the efficacy, target animal safety, and environmental assessment portions from the literature and compassionate INAD data for a NADA submission.
Human Chorionic Gonadotropin (HCG): Intervet. Inc. submitted a revised NADA package in October 1996 for final review by CVM. In February 1996, CVM ruled that enrollment in an INAD is not required to use HCG as a spawning aid. CVM will defer regulatory enforcement if it is used by or on order of a veterinarian. Any HCG product may be prescribed, but CVM strongly encourages the use of Intervet's product, Chorulon.
Luteinizing Hormone-Releasing Hormone Analog (LHRHa): AquaPharm Technologies Corporation canceled its IND/NADA in January 1997. The company hoped to sell its holdings to someone who would be interested in pursuing an aquaculture product. Several compassionate public INADs are active and waiting for new INAD sponsor.
Ovaprim, a gonadotropin-releasing hormone (GRH): Syndel International Inc. (Canada) recently obtained an INAD number for its gonadotropin releasing hormone analog product, Ovaprim. FWS and other INAD holders are working with Syndel to develop the technical sections of the NADA package.17a-methyltestosterone (MT): Auburn University developed an INAD application and protocol for MT as a gender manipulating aid on tilapia. The INAD was extended to yellow perch and walleye with the University of Wisconsin at Madison and a private veterinarian coordinating that portion of the INAD. Rangen, Inc., a feed manufacturer, is producing MT feed for the MT-INAD and is interested sponsoring the NADA. CVM will allow feed manufacturers that meet certain requirements to sponsor the MT-NADA because MT sales will be too low to interest a pharmaceutical sponsor. CVM reviewed Auburn University's human food safety portion of the NADA submission on MT and accepted MT as safe.
The coordinator will continue all activities to gain approval of compounds for use in aquaculture.
As a direct result of this project, the Center for Veterinary Medicine announced deferment of regulatory enforcement against the unapproved sales and use of an approved Human Chorionic Gonadotrophin product as a spawning aid in fish by or on the order of a licensed veterinarian. Also, CVM stated that formalin could be used safely on all fish eggs to control and prevent fungal infections if a statement is added to the label concerning the need for a preliminary bioassay on a sub-sample before the entire group is treated.