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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.

PMF # Drug/ Dosage Form/Route of Administration Indication and Species INAD Sponsor(s) Target Animal Safety Effectiveness Human Food Safety Environmental Impact 
003-883 Ivermectin/ Solution /Injection Treatment and control of gastrointestinal nematodes in goats USDA Minor Use Animal Drug Program 03/20/1989 03/20/1989 03/20/19894  
005-042 Lasalocid Sodium/ Type A Medicated Article/ Oral Control of coccidiosis associated with Eimeria spp. in pheasants USDA Minor Use Animal Drug Program   03/25/2011   02/04/2015
005-117 Levamisole hydrochloride/ powder for solution/Oral Treatment and control of gastrointestinal nematodes in goats USDA Minor Use Animal Drug Program 09/01/1989 09/01/1989   09/01/1989
005-165 Erythromycin thiocyanate/ Type A Medicated Article /Oral Control of mortality due to bacterial kidney disease associated with Renibacterium salmoninarum in freshwater-reared Chinook salmon USDA Minor Use Animal Drug Program

USFWS Aquatic Animal Drug Approval Partnership
11/07/2013 04/30/2012 08/30/20161,2,3,4  
005-206 Sulfamethazine/ Tablet/ Oral Treatment of bacterial pneumonia caused by Pasteurella spp. and colibacillosis caused by Escherichia coli in sheep USDA Minor Use Animal Drug Program 08/12/1988 04/05/1989    
005-316 Oxytetracycline/ Solution/ Injection Treatment of bacterial pneumonia caused by Pasteurella spp. in goats USDA Minor Use Animal Drug Program 08/17/1993     08/17/1993
005-321 Oxytetracycline/ Solution/ Injection Treatment of bacterial pneumonia caused by Pasteurella spp. in sheep USDA Minor Use Animal Drug Program 03/29/1994 10/30/1998   03/29/1994
005-351 Procaine penicillin G and novobiocin sodium/ suspension/ Intramammary Treatment for mastitis in dairy goats USDA Minor Use Animal Drug Program       11/18/1991
005-421 Ivermectin/ Solution/ Injection Control of ear mites Psoroptes cuniculi in rabbits USDA Minor Use Animal Drug Program   06/02/1993   12/02/2002
005-433 Amoxicillin trihydrate/ powder for suspension/ Injection Treatment of bacterial pneumonia due to Pasteurella spp and Haemophilus spp. in sheep USDA Minor Use Animal Drug Program 06/07/1999 06/07/1999 06/07/19994  
005-440 Clorsulon/ Suspension/ Oral Treatment of adult liver fluke, Fasciola hepatica, in goats USDA Minor Use Animal Drug Program 12/05/1996 12/05/1996 12/05/19964 12/05/1996
005-484 Ivermectin/ Solution/ Topical Treatment and control of the gastrointestinal nematode, Ostertagia ostertagi, in American Bison USDA Minor Use Animal Drug Program 04/28/2000 04/28/2000   04/28/2000
005-499 Ivermectin/ Solution/ Topical Treatment and control of various nematodes in red deer USDA Minor Use Animal Drug Program 12/07/1994 12/07/1994    
005-590 Copper Sulfate/ water soluble crystals /Aquatic Exposure Treatment of ichthyophthiriosis (Ichthyophthirius multifiliis) on all finfish  USDA ARS Aquaculture Research Center   12/15/1998 10/27/20081,2,3,4  
005-590 Copper Sulfate/ water soluble crystals /Aquatic Exposure Treatment of ichthyophthiriosis (Ichthyophthirius multifiliis) on channel catfish cultured in earthen ponds USDA ARS Aquaculture Research Center 04/21/2006 12/15/1998 10/27/20081,2,3,4

12/11/2015 Letter

12/11/2015 EA Appendix 13.1

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

National Center for Toxicological Research 
05/24/2010 06/12/2013 02/09/20043,4  
005-637 Chloramine-T/ water soluble powder/ Aquatic Exposure Prevention of mortality associated with bacterial gill disease in tiger muskellunge USGS Upper Midwest Environmental Sciences Center 02/27/2006 11/29/1999    
005-644 Fenbendazole/ Type A medicated article/ Oral Treatment of adult Heterakis gallinae and adult Syngamus trachea in pheasants USDA Minor Use Animal Drug Program   02/15/2000 04/04/20131,2,4  
005-644 Fenbendazole/ Type A medicated article/ Oral Removal and control of adult Syngamus trachea in pheasants USDA Minor Use Animal Drug Program 11/24/2014 02/15/2000 04/04/20131,2,4  
005-644 Fenbendazole/ Type A medicated article/ Oral Treatment of adult Heterakis gallinae and adult Capillaria spp in quail USDA Minor Use Animal Drug Program   02/15/2000    
005-644 Fenbendazole/ Type A medicated article/ Oral Treatment of adult Heterakis gallinae in partridge USDA Minor Use Animal Drug Program   02/15/2000    
005-646 Oxytetracycline/ Type A Medicated Article/ Oral Treatment of bacterial infections in finfish USGS Upper Midwest Environmental Sciences Center 12/19/2003      
005-662 Oxytetracycline dihydrate/ Type A medicated article/Oral Control of mortality associated with necrotizing hepatopancreatitis in penaeid shrimp University of Arizona

USFWS Aquatic Animal Drug Approval Partnership
10/29/2012 06/28/2000 10/13/20063,4  
005-662 Oxytetracycline dihydrate/ Type A medicated article/Oral Control of mortality associated with necrotizing hepatopancreatitis in penaeid shrimp University of Arizona

USFWS Aquatic Animal Drug Approval Partnership
    08/15/20062  
005-835 17- α methyltestosterone /Type C medicated feed/ Oral Use 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    
005-835 17- α methyltestosterone/ Type C medicated feed/ Oral Use of 17-α methyltestosterone (MT) Type C medicated feed for tilapia fry for the production of predominately (>80%) male populations of tilapia USFWS Aquatic Animal Drug Approval Partnership

USGS Upper Midwest Environmental Sciences Center

Auburn University/ Department of Fisheries and Allied Aquacultures
5/04/2012 12/10/2008 08/13/20101,2,3,4  
005-893
005-637
Chloramine-T/ water soluble powder/ Aquatic Exposure Control of mortality due to external columnaris disease associated with Flavobacterium columnare in freshwater-reared coolwater finfish USFWS Aquatic Animal Drug Approval Partnership

USGS Upper Midwest Environmental Sciences Center
02/27/2006 07/10/2015    
006-060 Eugenol /Liquid /Aquatic Exposure For the sedation of freshwater nonsalmonid finfish to a handleable condition USFWS Aquatic Animal Drug Approval Partnership 5/29/2014 5/16/2013    
006-060 Eugenol /Liquid /Aquatic Exposure For the sedation of freshwater salmonid finfish to a handleable condition USFWS Aquatic Animal Drug Approval Partnership 12/10/2013 5/16/2013    
006-061 Emamectin Benzoate/ Type A Medicated Article/Oral For the control of Salmincola californiensis in freshwater-reared Oncorhynchus mykiss USFWS Aquatic Animal Drug Approval Partnership 08/16/2013 04/13/2012    
006-082 Progesterone-impregnated controlled intravaginal drug release(CIDR) device/Solid Matrix/Intravaginal For use of progesterone-impregnated controlled intravaginal drug release (CIDR) device in goats USDA Minor Use Animal Drug Program 2/20/2008   8/12/20111,2,3,4 3/19/2012
006-143 Channel Catfish Pituitary / Powder, for Suspension/Injection Use of channel catfish pituitary as a spawning aid in female channel catfish (Ictalurus punctatus) USFWS Aquatic Animal Drug Approval Partnership      08/02/20101,2,3,4 08/26/2013
006-144 Crude Carp Pituitary / Powder, for Suspension/Injection Use of crude carp pituitary as a spawning aid in female finfish raised in freshwater USDA Minor Use Animal Drug Program

USFWS Aquatic Animal Drug Approval Partnership
  07/12/2002    
006-324 Strontium/Powder/ Aquatic Exposure skeletal marking of freshwater salmonid fry and fingerlings USDA Minor Use Animal Drug Program 5/31/2019      

 

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