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 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 | |
| 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 and control of Aulonocephalus spp. in wild quail | USDA Minor Use Animal Drug Program | 04/05/2023 | 04/10/2023 | 08/16/20221,2,4 | |
| 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 | ||
| 006-060 | Eugenol /Liquid /Aquatic Exposure | For the sedation of saltwater finfish to a handleable condition | USFWS Aquatic Animal Drug Approval Partnership | 09/30/2020 | |||
| 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 |