Animal & Veterinary

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, Effectiveness, and Environmental Impact 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 column headed Human Food Safety represent completion of a significant portion of that technical section of an NADA. These portions 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 AdministrationIndication and SpeciesINAD Sponsor(s)Target Animal SafetyEffectivenessHuman Food SafetyEnvironmental Impact 
003-883Ivermectin/ Solution /InjectionTreatment and control of gastrointestinal nematodes in goatsNRSP-703/20/198903/20/198903/20/19894 
005-042Lasalocid/ Type A Medicated Article/ OralControl of coccidiosis associated with Eimeria spp. in pheasantsNRSP-7 03/25/2011  
005-117Levamisole hydrochloride/ powder for solution/OralTreatment and control of gastrointestinal nematodes in goatsNRSP-709/01/198909/01/1989 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 salmonNRSP-7 USFWS/AADAP11/07/20134/30/20121/11/20071,2,4 
005-206Sulfamethazine/ Tablet/ OralTreatment of bacterial pneumonia caused by Pasteurella spp. and colibacillosis caused by Escherichia coli in sheepNRSP-708/12/198804/05/1989  
005-316Oxytetracycline/ Solution/ InjectionTreatment of bacterial pneumonia caused by Pasteurella spp. in goatsNRSP-708/17/1993  08/17/1993
005-321Oxytetracycline/ Solution/ InjectionTreatment of bacterial pneumonia caused by Pasteurella spp. in sheepNRSP-703/29/199410/30/1998 03/29/1994
005-351Procaine penicillin G and novobiocin sodium/ suspension/ IntramammaryTreatment for mastitis in dairy goatsNRSP-7   11/18/1991
005-421Ivermectin/ Solution/ InjectionControl of ear mites Psoroptes cuniculi in rabbitsNRSP-7 06/02/1993 12/02/2002
005-433Amoxicillin trihydrate/ powder for suspension/ InjectionTreatment of bacterial pneumonia due to Pasteurella spp and Haemophilus spp. in sheepNRSP-706/07/199906/07/199906/07/19994 
005-440Clorsulon/ Suspension/ OralTreatment of adult liver fluke, Fasciola hepatica, in goatsNRSP-712/05/199612/05/199612/05/1996412/05/1996
005-484Ivermectin/ Solution/ TopicalTreatment and control of the gastrointestinal nematode, Ostertagia ostertagi, in American BisonNRSP-704/28/200004/28/2000 04/28/2000
005-499Ivermectin/ Solution/ TopicalTreatment and control of various nematodes in red deerNRSP-712/07/199412/07/1994  
005-590Copper Sulfate/ water soluble crystals /Aquatic ExposurePrevention and treatment of Ichthyophthiriosis (Ich) in all freshwater reared finfish due to Ichthyophlhirius multifiliisUSDA ARS Aquaculture Research Center 12/15/199810/27/20081,2,3,4 
005-590Copper Sulfate/ water soluble crystals /Aquatic ExposureControl of mortality in channel catfish eggs due to saprolegniasis associated with fungi in the family Saprolegniaceae

USDA ARS Aquaculture Research Center

 

NCTR

05/24/2010 02/09/20043,4 
005-637Chloramine-T/ water soluble powder/ Aquatic ExposurePrevention of mortality associated with bacterial gill disease in tiger muskellungeUSGS/ UMESC02/27/200611/29/1999  
005-639Hydrogen Peroxide/ Liquid/ Aquatic exposureControl of mortality in freshwater-reared finfish due to saprolegniasis associated with fungi in the family SaprolegniaceaeUSGS/ UMESC 10/12/2011  
005-639Hydrogen Peroxide/ Liquid/ Aquatic exposureTreatment and control of Gyrodactylus spp. In freshwater-reared salmonids

USFWS/ AADAP

USGS/ UMESC
 

 08/06/2012  
005-639Hydrogen Peroxide/ Liquid/ Aquatic exposureControl of mortality due to external columnaris associated with Flavobacterium columnare in freshwater-reared warmwater finfishUSFWS/ AADAP 08/26/2009  
005-644Fenbendazole/ Type A medicated article/ OralTreatment of adult Heterakis gallinae and adult Syngamus trachea in pheasantsNRSP-7 02/15/200004/04/20131,2,4 
005-644Fenbendazole/ Type A medicated article/ OralTreatment of adult Heterakis gallinae and adult Capillaria spp in quailNRSP-7 02/15/2000  
005-644Fenbendazole/ Type A medicated article/ OralTreatment of adult Heterakis gallinae in partridgeNRSP-7 02/15/2000  
005-646Oxytetracycline/ Type A Medicated Article/ OralTreatment of bacterial infections in finfishUSGS/ UMESC12/19/2003   
006-060Eugenol /Liquid /Aquatic ExposureFor the sedation of freshwater nonsalmonid finfish to a handleable conditionUSFWS/ AADAP5/29/20145/16/2013  
006-060Eugenol /Liquid /Aquatic ExposureFor the sedation of freshwater salmonid finfish to a handleable conditionUSFWS/ AADAP12/10/20135/16/2013  
006-061Emamectin Benzoate/ Type A Medicated Article/OralFor the control of Salmincola californiensis in freshwater-reared Oncorhynchus mykissUSFWS/ AADAP08/16/201304/13/2012  
006-082Progesterone-impregnated controlled intravaginal drug release(CIDR) device/Solid Matrix/IntravaginalFor use of progesterone-impregnated controlled intravaginal drug release (CIDR) device in goatsNRSP-72/20/2008 8/12/20111,2,3,43/19/2012

 

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