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Public Master Files (PMFs) in development

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The dates in the following table represent work to support the approval of new animal drug applications (NADAs) that has been done by public entities. The dates in columns headed Target Animal Safety and Effectiveness represent the completion of all of the work determined to be necessary to support that technical section of an NADA on the date appearing in the table. Dates in the columns headed Human Food Safety and Environmental Impact represent completion of a significant portion of that technical section of an NADA. The completed portions of the Human Food Safety technical section are represented by the following footnotes in the table:

1-microbial food safety - antimicrobial resistance
2-microbial food safety - impact on human intestinal flora
3-toxicology
4-residue chemistry

Even when dates are present in all columns it does not represent a complete approval package. Technical sections completed in a PMF will typically not include the Chemistry, Manufacturing, and Controls (CMC) section, the toxicology portion of the Human Food Safety section or the labeling section. These technical sections are typically in a proprietary file belonging to a pharmaceutical sponsor. Sponsors for applications for food producing animals need to own the toxicology data or have a right of reference to use such data owned by another sponsor to complete the human food safety technical section.

The absence of a date in a column does not necessarily mean that no work has been done by public entities, only that sufficient work has not been done to warrant issuance of a Technical Section Complete (TSC) letter or to complete a significant portion of the Human Food safety section of an NADA.

Note: While the conclusions that FDA reached in the review of studies submitted to us and reflected in the letters represented in the table are generally sufficient to support those portions of an application, the validity of these determinations may be affected by advancing scientific knowledge, changing requirements, or significant passages of time. The contact information provided in the letters may also no longer be valid due to the passage of time. If you have questions about any of the PMFs in development, please contact AskCVM@fda.hhs.gov.

PMF #Drug/ Dosage Form/Route of AdministrationIndication and SpeciesINAD Sponsor(s)Target Animal SafetyEffectivenessHuman Food SafetyEnvironmental Impact 
003-883Ivermectin/ Solution /InjectionTreatment and control of gastrointestinal nematodes in goatsUSDA Minor Use Animal Drug Program03/20/198903/20/198903/20/19894 
005-042Lasalocid Sodium/ Type A Medicated Article/ OralControl of coccidiosis associated with Eimeria spp. in pheasantsUSDA Minor Use Animal Drug Program 03/25/2011 02/04/2015
005-117Levamisole hydrochloride/ powder for solution/OralTreatment and control of gastrointestinal nematodes in goatsUSDA Minor Use Animal Drug Program09/01/198909/01/1989 09/01/1989
005-165Erythromycin thiocyanate/ Type A Medicated Article /OralControl of mortality due to bacterial kidney disease associated with Renibacterium salmoninarum in freshwater-reared Chinook salmonUSDA Minor Use Animal Drug Program

USFWS Aquatic Animal Drug Approval Partnership
11/07/201304/30/201208/30/20161,2,3,4 
005-206Sulfamethazine/ Tablet/ OralTreatment of bacterial pneumonia caused by Pasteurella spp. and colibacillosis caused by Escherichia coli in sheepUSDA Minor Use Animal Drug Program08/12/198804/05/1989  
005-316Oxytetracycline/ Solution/ InjectionTreatment of bacterial pneumonia caused by Pasteurella spp. in goatsUSDA Minor Use Animal Drug Program08/17/1993  08/17/1993
005-321Oxytetracycline/ Solution/ InjectionTreatment of bacterial pneumonia caused by Pasteurella spp. in sheepUSDA Minor Use Animal Drug Program03/29/199410/30/1998 03/29/1994
005-351Procaine penicillin G and novobiocin sodium/ suspension/ IntramammaryTreatment for mastitis in dairy goatsUSDA Minor Use Animal Drug Program   11/18/1991
005-421Ivermectin/ Solution/ InjectionControl of ear mites Psoroptes cuniculi in rabbitsUSDA Minor Use Animal Drug Program 06/02/1993 12/02/2002
005-433Amoxicillin trihydrate/ powder for suspension/ InjectionTreatment of bacterial pneumonia due to Pasteurella spp and Haemophilus spp. in sheepUSDA Minor Use Animal Drug Program06/07/199906/07/199906/07/19994 
005-440Clorsulon/ Suspension/ OralTreatment of adult liver fluke, Fasciola hepatica, in goatsUSDA Minor Use Animal Drug Program12/05/199612/05/199612/05/1996412/05/1996
005-484Ivermectin/ Solution/ TopicalTreatment and control of the gastrointestinal nematode, Ostertagia ostertagi, in American BisonUSDA Minor Use Animal Drug Program04/28/200004/28/2000 04/28/2000
005-499Ivermectin/ Solution/ TopicalTreatment and control of various nematodes in red deerUSDA Minor Use Animal Drug Program12/07/199412/07/1994  
005-590Copper Sulfate/ water soluble crystals /Aquatic ExposureTreatment of ichthyophthiriosis (Ichthyophthirius multifiliis) on all finfish USDA ARS Aquaculture Research Center 12/15/199810/27/20081,2,3,4 
005-590Copper Sulfate/ water soluble crystals /Aquatic ExposureTreatment of ichthyophthiriosis (Ichthyophthirius multifiliis) on channel catfish cultured in earthen pondsUSDA ARS Aquaculture Research Center04/21/200612/15/199810/27/20081,2,3,4

12/11/2015 Letter

12/11/2015 EA Appendix 13.1

005-590Copper Sulfate/ water soluble crystals /Aquatic ExposureControl of mortality in channel catfish eggs due to saprolegniasis associated with fungi in the family SaprolegniaceaeUSDA ARS Aquaculture Research Center

National Center for Toxicological Research 
05/24/201006/12/201302/09/20043,4 
005-637Chloramine-T/ water soluble powder/ Aquatic ExposurePrevention of mortality associated with bacterial gill disease in tiger muskellungeUSGS Upper Midwest Environmental Sciences Center02/27/200611/29/1999  
005-644Fenbendazole/ Type A medicated article/ OralTreatment of adult Heterakis gallinae and adult Syngamus trachea in pheasantsUSDA Minor Use Animal Drug Program 02/15/200004/04/20131,2,4 
005-644Fenbendazole/ Type A medicated article/ OralRemoval and control of adult Syngamus trachea in pheasantsUSDA Minor Use Animal Drug Program11/24/201402/15/200004/04/20131,2,4 
005-644Fenbendazole/ Type A medicated article/ OralTreatment of adult Heterakis gallinae and adult Capillaria spp in quailUSDA Minor Use Animal Drug Program01/28/202502/15/2000  
005-644Fenbendazole/ Type A medicated article/ OralTreatment of adult Heterakis gallinae in partridgeUSDA Minor Use Animal Drug Program 02/15/2000  
005-646Oxytetracycline/ Type A Medicated Article/ OralTreatment of bacterial infections in finfishUSGS Upper Midwest Environmental Sciences Center12/19/2003   
005-662Oxytetracycline dihydrate/ Type A medicated article/OralControl of mortality associated with necrotizing hepatopancreatitis in penaeid shrimpUniversity of Arizona

USFWS Aquatic Animal Drug Approval Partnership
10/29/201206/28/200010/13/20063,4 
005-662Oxytetracycline dihydrate/ Type A medicated article/OralControl of mortality associated with necrotizing hepatopancreatitis in penaeid shrimpUniversity of Arizona

USFWS Aquatic Animal Drug Approval Partnership
  08/15/20062 
005-83517- α methyltestosterone /Type C medicated feed/ OralUse of 17-α methyltestosterone in feed to increase the proportion of phenotypic males in swordtails (Xiphophorus hellerii)University of Florida/ Tropical Aquaculture Laboratory 04/30/2010  
005-83517- α methyltestosterone/ Type C medicated feed/ OralUse of 17-α methyltestosterone (MT) Type C medicated feed for tilapia fry for the production of predominately (>80%) male populations of tilapiaUSFWS Aquatic Animal Drug Approval Partnership

USGS Upper Midwest Environmental Sciences Center

Auburn University/ Department of Fisheries and Allied Aquacultures
5/04/201212/10/200808/13/20101,2,3,4 
005-893
005-637
Chloramine-T/ water soluble powder/ Aquatic ExposureControl of mortality due to external columnaris disease associated with Flavobacterium columnare in freshwater-reared coolwater finfishUSFWS Aquatic Animal Drug Approval Partnership

USGS Upper Midwest Environmental Sciences Center
02/27/200607/10/2015  
006-060Eugenol /Liquid /Aquatic ExposureFor the sedation of freshwater nonsalmonid finfish to a handleable conditionUSFWS Aquatic Animal Drug Approval Partnership5/29/20145/16/2013  
006-060Eugenol /Liquid /Aquatic ExposureFor the sedation of freshwater salmonid finfish to a handleable conditionUSFWS Aquatic Animal Drug Approval Partnership12/10/20135/16/2013  
006-060Eugenol /Liquid /Aquatic ExposureFor the sedation of saltwater finfish to a handleable conditionUSFWS Aquatic Animal Drug Approval Partnership 09/30/2020  
006-061Emamectin Benzoate/ Type A Medicated Article/OralFor the control of Salmincola californiensis in freshwater-reared Oncorhynchus mykissUSFWS Aquatic Animal Drug Approval Partnership08/16/201304/13/2012  
006-082Progesterone-impregnated controlled intravaginal drug release(CIDR) device/Solid Matrix/IntravaginalFor use of progesterone-impregnated controlled intravaginal drug release (CIDR) device in goatsUSDA Minor Use Animal Drug Program2/20/2008 8/12/20111,2,3,43/19/2012
006-143Channel Catfish Pituitary / Powder, for Suspension/InjectionUse of channel catfish pituitary as a spawning aid in female channel catfish (Ictalurus punctatus)USFWS Aquatic Animal Drug Approval Partnership   08/02/20101,2,3,408/26/2013
006-144Crude Carp Pituitary / Powder, for Suspension/InjectionUse of crude carp pituitary as a spawning aid in female finfish raised in freshwaterUSDA Minor Use Animal Drug Program

USFWS Aquatic Animal Drug Approval Partnership
 07/12/2002  
006-324Strontium/Powder/ Aquatic Exposureskeletal marking of freshwater salmonid fry and fingerlingsUSDA Minor Use Animal Drug Program5/31/2019   

 

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