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227 rows where docket_id = "FDA-2017-P-5787" sorted by posted_date descending

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id agency_id docket_id title document_type subtype posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id
FDA-2017-P-5787-0242 FDA None FDA-2017-P-5787 Final Response Letter from FDA CDER to Post-Finasteride Syndrome Foundation Other Response(s) 2022-06-09T04:00:00Z 2022 6 2022-06-09T04:00:00Z   2022-06-09T11:35:13Z   0 0 090000648515084c
FDA-2017-P-5787-0231 FDA None FDA-2017-P-5787 Melcangi_Methylation of SRD5A2 in CSF of PFS Pts (Endocr Connect 2019) Supporting & Related Material Background Material 2020-12-03T05:00:00Z 2020 12     2020-12-03T16:07:15Z   0 0 0900006484984797
FDA-2017-P-5787-0222 FDA None FDA-2017-P-5787 CMDh Recommendation re Anxiety in Propecia SPC_EMA (Apr 2018) Supporting & Related Material Background Material 2020-12-03T05:00:00Z 2020 12     2020-12-03T15:27:24Z   0 0 0900006484984768
FDA-2017-P-5787-0223 FDA None FDA-2017-P-5787 Diviccaro_Finasteride, Hippocampal Neurogenesis and Neuroinflammation in Rats (Psychneuroendocrin 2019) Supporting & Related Material Background Material 2020-12-03T05:00:00Z 2020 12     2020-12-03T15:28:17Z   0 0 0900006484984769
FDA-2017-P-5787-0230 FDA None FDA-2017-P-5787 Levine_Court let Merck hide secrets (Reuters 9-11-19) Supporting & Related Material Background Material 2020-12-03T05:00:00Z 2020 12     2020-12-03T16:06:26Z   0 0 0900006484984796
FDA-2017-P-5787-0232 FDA None FDA-2017-P-5787 Nguyen and Trinh_Suicidality and Psychological AEs w Finasteride (JAMA Derm 2020) Supporting & Related Material Background Material 2020-12-03T05:00:00Z 2020 12     2020-12-03T16:09:31Z   0 0 0900006484984798
FDA-2017-P-5787-0241 FDA None FDA-2017-P-5787 Summary of Product Characteristics_ANSM_English (Dec 2019) Supporting & Related Material Background Material 2020-12-03T05:00:00Z 2020 12     2020-12-03T16:34:25Z   0 0 090000648498449a
FDA-2017-P-5787-0224 FDA None FDA-2017-P-5787 Gulbinovic_Final Assessment Report of PSUR (Sweden MPA 2007) Supporting & Related Material Background Material 2020-12-03T05:00:00Z 2020 12     2020-12-03T15:29:58Z   0 0 0900006484984791
FDA-2017-P-5787-0235 FDA None FDA-2017-P-5787 Petition Supplement 2 Post-Finasteride Syndrome Foundation Notice Background Material 2020-12-03T05:00:00Z 2020 12     2020-12-03T17:17:17Z   0 0 0900006484984494
FDA-2017-P-5787-0226 FDA None FDA-2017-P-5787 Kaufman_Finasteride Rx for AGA (J Am Acad Dermatol 1998) Supporting & Related Material Background Material 2020-12-03T05:00:00Z 2020 12     2020-12-03T15:31:57Z   0 0 0900006484984793
FDA-2017-P-5787-0228 FDA None FDA-2017-P-5787 Khera and Mirabel_Penile Vascular Abnormalities in PFS (Translat Androl Urol 2020) Supporting & Related Material Background Material 2020-12-03T05:00:00Z 2020 12     2020-12-03T15:46:53Z   0 0 0900006484984794
FDA-2017-P-5787-0236 FDA None FDA-2017-P-5787 Propecia Proposed Prescribing Info_Revision Marks (2002) Supporting & Related Material Background Material 2020-12-03T05:00:00Z 2020 12     2020-12-03T16:27:53Z   0 0 0900006484984495
FDA-2017-P-5787-0238 FDA None FDA-2017-P-5787 Propecia Summary of Product Characteristics_MHRA UK (Jun 2018) Supporting & Related Material Background Material 2020-12-03T05:00:00Z 2020 12     2020-12-03T16:29:49Z   0 0 0900006484984497
FDA-2017-P-5787-0240 FDA None FDA-2017-P-5787 Reminder of Risk of Psychiatric and Sexual Disorders_ANSM webpage (Feb 2019) Supporting & Related Material Background Material 2020-12-03T05:00:00Z 2020 12     2020-12-03T16:33:26Z   0 0 0900006484984499
FDA-2017-P-5787-0237 FDA None FDA-2017-P-5787 Propecia Summary of Product Characteristics_ANSM France (Dec 2019) Supporting & Related Material Background Material 2020-12-03T05:00:00Z 2020 12     2020-12-03T16:28:52Z   0 0 0900006484984496
FDA-2017-P-5787-0225 FDA None FDA-2017-P-5787 Irwig_Finasteride and Suicide Case Series (Dermatol 2020) Supporting & Related Material Background Material 2020-12-03T05:00:00Z 2020 12     2020-12-03T15:30:45Z   0 0 0900006484984792
FDA-2017-P-5787-0229 FDA None FDA-2017-P-5787 Letter to Health Professionals_Reminder of Risk of Psychiatric and Sexual Disorders_ANSM France (Feb 2019) Supporting & Related Material Background Material 2020-12-03T05:00:00Z 2020 12     2020-12-03T15:52:35Z   0 0 0900006484984795
FDA-2017-P-5787-0227 FDA None FDA-2017-P-5787 Godar and Bortolato_Finasteride Reduces Response to Stressful and Rewarding Stimuli (Biomolec 2019) Supporting & Related Material Background Material 2020-12-03T05:00:00Z 2020 12     2020-12-03T15:41:44Z   0 0 0900006484984790
FDA-2017-P-5787-0233 FDA None FDA-2017-P-5787 Periodic Safety Update Report _19_Merck (Nov 2006) Supporting & Related Material Background Material 2020-12-03T05:00:00Z 2020 12     2020-12-03T16:24:23Z   0 0 0900006484984799
FDA-2017-P-5787-0234 FDA None FDA-2017-P-5787 Petition Supplement 1 Post-Finasteride Syndrome Foundation Notice Background Material 2020-12-03T05:00:00Z 2020 12     2020-12-03T17:16:41Z   0 0 0900006484984493
FDA-2017-P-5787-0239 FDA None FDA-2017-P-5787 Red Hand Letter re Finasteride_BfArM Germany (Jul 2018) Supporting & Related Material Background Material 2020-12-03T05:00:00Z 2020 12     2020-12-03T16:30:50Z   0 0 0900006484984498
FDA-2017-P-5787-0221 FDA None FDA-2017-P-5787 Interim Response from FDA to Post-Finasteride Syndrome Foundation Other Response(s) 2018-03-16T04:00:00Z 2018 3 2018-03-16T04:00:00Z   2018-03-16T12:56:22Z   0 0 090000648301baba
FDA-2017-P-5787-0205 FDA None FDA-2017-P-5787 Table of Contents re Citizen Petition Post- Finasteride Syndrome Foundation Supporting & Related Material List 2017-09-28T04:00:00Z 2017 9     2017-09-29T12:56:49Z   0 0 0900006482b732fe
FDA-2017-P-5787-0065 FDA None FDA-2017-P-5787 Reference 63 Hamilton_Male Hormone Stimulation and Baldness (Amer J Anat 1942) re Citizen Petition Post- Finasteride Syndrome Foundation Supporting & Related Material Background Material 2017-09-21T04:00:00Z 2017 9     2017-09-21T20:52:33Z   0 0 0900006482b65d56
FDA-2017-P-5787-0117 FDA None FDA-2017-P-5787 Reference 115 MedWatch FDA Form 3500_PFSS#7 continued (30-May-2017) re Citizen Petition Post- Finasteride Syndrome Foundation Supporting & Related Material Background Material 2017-09-21T04:00:00Z 2017 9     2017-09-21T20:56:06Z   0 0 0900006482b65dbe
FDA-2017-P-5787-0119 FDA None FDA-2017-P-5787 Reference 117 MedWatch FDA Form 3500_PFSS#8 continued (28-May-2017) re Citizen Petition Post- Finasteride Syndrome Foundation Supporting & Related Material Background Material 2017-09-21T04:00:00Z 2017 9     2017-09-21T20:56:12Z   0 0 0900006482b65dc0
FDA-2017-P-5787-0007 FDA None FDA-2017-P-5787 Reference 5 Andersson_Cloned human and rat steroid 5α-reductases (PNAS 1990) re Citizen Petition Post- Finasteride Syndrome Foundation Supporting & Related Material Background Material 2017-09-21T04:00:00Z 2017 9     2017-09-21T20:44:54Z   0 0 0900006482b650a9
FDA-2017-P-5787-0011 FDA None FDA-2017-P-5787 Reference 9 Antiandrogen Drugs Definition (Free Online Medical Dictionary, Thesaurus and Encyclopedia 2013) re Citizen Petition Post- Finasteride Syndrome Foundation Supporting & Related Material Background Material 2017-09-21T04:00:00Z 2017 9     2017-09-21T20:45:18Z   0 0 0900006482b658b5
FDA-2017-P-5787-0030 FDA None FDA-2017-P-5787 Reference 28 Castro-Magana_Finasteride and Human Testicular Steroidogenesis (J Androl 1996) re Citizen Petition Post- Finasteride Syndrome Foundation Supporting & Related Material Background Material 2017-09-21T04:00:00Z 2017 9     2017-09-21T20:50:07Z   0 0 0900006482b658d9
FDA-2017-P-5787-0165 FDA None FDA-2017-P-5787 Reference 163 Schultheiss_AR and ER in Human Corpus Cavernosum (World J Urol 2003) re Citizen Petition Post- Finasteride Syndrome Foundation Supporting & Related Material Background Material 2017-09-21T04:00:00Z 2017 9     2017-09-21T20:59:15Z   0 0 0900006482b65e86
FDA-2017-P-5787-0191 FDA None FDA-2017-P-5787 Reference 189 Trybek_AR in the Epididymis of Rats with DHT Deficiency (Reprod Biol 2005) re Citizen Petition Post- Finasteride Syndrome Foundation Supporting & Related Material Background Material 2017-09-21T04:00:00Z 2017 9     2017-09-21T21:01:01Z   0 0 0900006482b65ebe
FDA-2017-P-5787-0021 FDA None FDA-2017-P-5787 Reference 19 Bruchovsky_Intranuclear Binding of T in Rat Prostate (J Biol Chem 1968) re Citizen Petition Post- Finasteride Syndrome Foundation Supporting & Related Material Background Material 2017-09-21T04:00:00Z 2017 9     2017-09-21T20:49:28Z   0 0 0900006482b65920
FDA-2017-P-5787-0023 FDA None FDA-2017-P-5787 Reference 21 Bull_Mechanism-Based Inhibition of Human 5AR (J Am Chem Soc 1996) re Citizen Petition Post- Finasteride Syndrome Foundation Supporting & Related Material Background Material 2017-09-21T04:00:00Z 2017 9     2017-09-21T20:49:37Z   0 0 0900006482b65922
FDA-2017-P-5787-0106 FDA None FDA-2017-P-5787 Reference 104 MedWatch FDA Form 3500_PFSS#2 3500 (24-May-2017) re Citizen Petition Post- Finasteride Syndrome Foundation Supporting & Related Material Background Material 2017-09-21T04:00:00Z 2017 9     2017-09-21T20:55:19Z   0 0 0900006482b65ab0
FDA-2017-P-5787-0115 FDA None FDA-2017-P-5787 Reference 113 MedWatch FDA Form 3500_PFSS#6 continued (29-May-2017) re Citizen Petition Post- Finasteride Syndrome Foundation Supporting & Related Material Background Material 2017-09-21T04:00:00Z 2017 9     2017-09-21T20:55:59Z   0 0 0900006482b65acd
FDA-2017-P-5787-0116 FDA None FDA-2017-P-5787 Reference 114 MedWatch FDA Form 3500_PFSS#7 (30-May-2017) re Citizen Petition Post- Finasteride Syndrome Foundation Supporting & Related Material Background Material 2017-09-21T04:00:00Z 2017 9     2017-09-21T20:56:03Z   0 0 0900006482b65ace
FDA-2017-P-5787-0129 FDA None FDA-2017-P-5787 Reference 127 Nonomura_Androgen Binding in Mammalian Penis (J Urol 1990) re Citizen Petition Post- Finasteride Syndrome Foundation Supporting & Related Material Background Material 2017-09-21T04:00:00Z 2017 9     2017-09-21T20:56:47Z   0 0 0900006482b65afe
FDA-2017-P-5787-0184 FDA None FDA-2017-P-5787 Reference 182 Tindall_5ARIs in PC (J Urol 2008) re Citizen Petition Post- Finasteride Syndrome Foundation Supporting & Related Material Background Material 2017-09-21T04:00:00Z 2017 9     2017-09-21T21:00:26Z   0 0 0900006482b65b79
FDA-2017-P-5787-0029 FDA None FDA-2017-P-5787 Reference 27 Castelli_Regional Distribution of 5AR2 in Rat Brain_Table 1 (Psychoneuroendocrin 2013) re Citizen Petition Post- Finasteride Syndrome Foundation Supporting & Related Material Background Material 2017-09-21T04:00:00Z 2017 9     2017-09-21T20:50:02Z   0 0 0900006482b658d8
FDA-2017-P-5787-0157 FDA None FDA-2017-P-5787 Reference 155 Roberts_Clinical Dose Ranging Studies w Finasteride for MPHL (J Am Acad Dermatol 1999) re Citizen Petition Post- Finasteride Syndrome Foundation Supporting & Related Material Background Material 2017-09-21T04:00:00Z 2017 9     2017-09-21T20:58:46Z   0 0 0900006482b65e58
FDA-2017-P-5787-0075 FDA None FDA-2017-P-5787 Reference 73 Irwig_Finasteride and Persistent Sexual Side Effects (J Sex Med 2011) re Citizen Petition Post- Finasteride Syndrome Foundation Supporting & Related Material Background Material 2017-09-21T04:00:00Z 2017 9     2017-09-21T20:53:18Z   0 0 0900006482b65a24
FDA-2017-P-5787-0087 FDA None FDA-2017-P-5787 Reference 85 Ko_CDER Medical Review_NDA 20-788_P3 (Dec-1997) re Citizen Petition Post- Finasteride Syndrome Foundation Supporting & Related Material Background Material 2017-09-21T04:00:00Z 2017 9     2017-09-21T20:54:02Z   0 0 0900006482b65a87
FDA-2017-P-5787-0198 FDA None FDA-2017-P-5787 Reference 196 Wessells_PLESS_Sexual AEs in BPH (Urology 2003) re Citizen Petition Post- Finasteride Syndrome Foundation Supporting & Related Material Background Material 2017-09-21T04:00:00Z 2017 9     2017-09-21T21:01:25Z   0 0 0900006482b65ba8
FDA-2017-P-5787-0201 FDA None FDA-2017-P-5787 Reference 199 Wu_Reproductive AEs w Alopecia Drugs (Oncotarget 2016) re Citizen Petition Post- Finasteride Syndrome Foundation Supporting & Related Material Background Material 2017-09-21T04:00:00Z 2017 9     2017-09-21T21:01:35Z   0 0 0900006482b65bab
FDA-2017-P-5787-0141 FDA None FDA-2017-P-5787 Reference 139 Presti_Finasteride for Stage D PC (J Urol 1992) re Citizen Petition Post- Finasteride Syndrome Foundation Supporting & Related Material Background Material 2017-09-21T04:00:00Z 2017 9     2017-09-21T20:57:35Z   0 0 0900006482b65e1e
FDA-2017-P-5787-0101 FDA None FDA-2017-P-5787 Reference 99 Mantzoros_DHT and Male Sexual Behavior (BMJ 1995) re Citizen Petition Post- Finasteride Syndrome Foundation Supporting & Related Material Background Material 2017-09-21T04:00:00Z 2017 9     2017-09-21T20:55:02Z   0 0 0900006482b65aab
FDA-2017-P-5787-0134 FDA None FDA-2017-P-5787 Reference 132 Park_Androgens and NOS mRNA in Rat Corpus Cavernosum (BJU Int 1999) re Citizen Petition Post- Finasteride Syndrome Foundation Supporting & Related Material Background Material 2017-09-21T04:00:00Z 2017 9     2017-09-21T20:57:07Z   0 0 0900006482b65b03
FDA-2017-P-5787-0145 FDA None FDA-2017-P-5787 Reference 143 Propecia Full Prescribing Info (31-Jan-2014) re Citizen Petition Post- Finasteride Syndrome Foundation Supporting & Related Material Background Material 2017-09-21T04:00:00Z 2017 9     2017-09-21T20:57:51Z   0 0 0900006482b65b27
FDA-2017-P-5787-0178 FDA None FDA-2017-P-5787 Reference 176 Suzuki_PK and Binding of Finasteride to 5AR1 and 5AR2 (Drug Metab Pharmacokin 2010) Supporting & Related Material Background Material 2017-09-21T04:00:00Z 2017 9     2017-09-21T21:00:04Z   0 0 0900006482b65b73
FDA-2017-P-5787-0179 FDA None FDA-2017-P-5787 Reference 177 Tay_Finasteride in Adenoca of Prostate (Ann Onc 2004) re Citizen Petition Post- Finasteride Syndrome Foundation Supporting & Related Material Background Material 2017-09-21T04:00:00Z 2017 9     2017-09-21T21:00:08Z   0 0 0900006482b65b74
FDA-2017-P-5787-0139 FDA None FDA-2017-P-5787 Reference 137 Poletti_Androgen Activating Enzymes in CNS (J Steroid Biochem Mol Biol 1999) re Citizen Petition Post- Finasteride Syndrome Foundation Supporting & Related Material Background Material 2017-09-21T04:00:00Z 2017 9     2017-09-21T20:57:28Z   0 0 0900006482b65e1c
FDA-2017-P-5787-0143 FDA None FDA-2017-P-5787 Reference 141 Propecia Full Prescribing Info (8-Dec-2001) re Citizen Petition Post- Finasteride Syndrome Foundation Supporting & Related Material Background Material 2017-09-21T04:00:00Z 2017 9     2017-09-21T20:57:43Z   0 0 0900006482b65e20
FDA-2017-P-5787-0071 FDA None FDA-2017-P-5787 Reference 69 Imperato-McGinley_C19 and C21 Metabolites w Finasteride and 5AR2 Deficiency (JCEM 1990) re Citizen Petition Post- Finasteride Syndrome Foundation Supporting & Related Material Background Material 2017-09-21T04:00:00Z 2017 9     2017-09-21T20:53:04Z   0 0 0900006482b65a20
FDA-2017-P-5787-0057 FDA None FDA-2017-P-5787 Reference 55 Glina_Finasteride and Infertility (Rev Hosp Clin 2004) re Citizen Petition Post- Finasteride Syndrome Foundation Supporting & Related Material Background Material 2017-09-21T04:00:00Z 2017 9     2017-09-21T20:52:04Z   0 0 0900006482b65d4e
FDA-2017-P-5787-0060 FDA None FDA-2017-P-5787 Reference 58 Gormley_Treating AGA with 5-Alpha Reductase Inhibitors_U.S. Patent # 5,547,957 (20-Aug-1996) re Citizen Petition Post- Finasteride Syndrome Foundation Supporting & Related Material Background Material 2017-09-21T04:00:00Z 2017 9     2017-09-21T20:52:15Z   0 0 0900006482b65d51
FDA-2017-P-5787-0012 FDA None FDA-2017-P-5787 Reference 10 Aumuller_Localization of 5AR Isoenzymes in Human Tissue (Acta Anat 1996) re Citizen Petition Post- Finasteride Syndrome Foundation Supporting & Related Material Background Material 2017-09-21T04:00:00Z 2017 9     2017-09-21T20:45:22Z   0 0 0900006482b658b6
FDA-2017-P-5787-0028 FDA None FDA-2017-P-5787 Reference 26 Castelli_Regional Distribution of 5AR2 in Rat Brain (Psychoneuroendocrin 2013) re Citizen Petition Post- Finasteride Syndrome Foundation Supporting & Related Material Background Material 2017-09-21T04:00:00Z 2017 9     2017-09-21T20:49:59Z   0 0 0900006482b658d7
FDA-2017-P-5787-0054 FDA None FDA-2017-P-5787 Reference 52 Geller_Castration-Like Effects of Finasteride on Prostate (J Cell Biochem 1992) re Citizen Petition Post- Finasteride Syndrome Foundation Supporting & Related Material Background Material 2017-09-21T04:00:00Z 2017 9     2017-09-21T20:51:52Z   0 0 0900006482b659f2
FDA-2017-P-5787-0069 FDA None FDA-2017-P-5787 Reference 67 Imperato-McGinley_5AR Deficiency and Pseudohermaphrotism (Science 1974) re Citizen Petition Post- Finasteride Syndrome Foundation Supporting & Related Material Background Material 2017-09-21T04:00:00Z 2017 9     2017-09-21T20:52:57Z   0 0 0900006482b65a1e
FDA-2017-P-5787-0093 FDA None FDA-2017-P-5787 Reference 91 Labrie_Serum Steroid Precursors and Androgen Metabolites (J Clin Endocrinol Metab 1997) re Citizen Petition Post- Finasteride Syndrome Foundation Supporting & Related Material Background Material 2017-09-21T04:00:00Z 2017 9     2017-09-21T20:54:33Z   0 0 0900006482b65a8d
FDA-2017-P-5787-0199 FDA None FDA-2017-P-5787 Reference 197 Whiting_Finasteride 1 mg in MPHL age 41-60 (Eur J Dermotol 2003) re Citizen Petition Post- Finasteride Syndrome Foundation Supporting & Related Material Background Material 2017-09-21T04:00:00Z 2017 9     2017-09-21T21:01:28Z   0 0 0900006482b65ba9
FDA-2017-P-5787-0202 FDA None FDA-2017-P-5787 Reference 200 Yamana_Type 3 5AR inhibition by finasteride and dutasteride (Horm Mol Clin Invest 2010) re Citizen Petition Post- Finasteride Syndrome Foundation Supporting & Related Material Background Material 2017-09-21T04:00:00Z 2017 9     2017-09-21T21:01:38Z   0 0 0900006482b65bac
FDA-2017-P-5787-0098 FDA None FDA-2017-P-5787 Reference 96 Lugg_DHT and NO Penile Erection in the the Rat (Endocrin 1995) re Citizen Petition Post- Finasteride Syndrome Foundation Supporting & Related Material Background Material 2017-09-21T04:00:00Z 2017 9     2017-09-21T20:54:50Z   0 0 0900006482b65aa8
FDA-2017-P-5787-0111 FDA None FDA-2017-P-5787 Reference 109 MedWatch FDA Form 3500_PFSS#4 continued (26-May-2017) re Citizen Petition Post- Finasteride Syndrome Foundation Supporting & Related Material Background Material 2017-09-21T04:00:00Z 2017 9     2017-09-21T20:55:46Z   0 0 0900006482b65ac9
FDA-2017-P-5787-0127 FDA None FDA-2017-P-5787 Reference 125 Moore_Finasteride and Uncertainty in Establishing Harm (JAMA Derm 2015) re Citizen Petition Post- Finasteride Syndrome Foundation Supporting & Related Material Background Material 2017-09-21T04:00:00Z 2017 9     2017-09-21T20:56:39Z   0 0 0900006482b65afa
FDA-2017-P-5787-0131 FDA None FDA-2017-P-5787 Reference 129 O'Donnell_T-Dependent Spermatogenesis in Rats and 5ARI (J Androl 1999) re Citizen Petition Post- Finasteride Syndrome Foundation Supporting & Related Material Background Material 2017-09-21T04:00:00Z 2017 9     2017-09-21T20:56:56Z   0 0 0900006482b65b00
FDA-2017-P-5787-0152 FDA None FDA-2017-P-5787 Reference 150 Rittmaster_Adiol-G in Liver, Skin and Prostate (JCEM 1993) re Citizen Petition Post- Finasteride Syndrome Foundation Supporting & Related Material Background Material 2017-09-21T04:00:00Z 2017 9     2017-09-21T20:58:25Z   0 0 0900006482b65b2e
FDA-2017-P-5787-0180 FDA None FDA-2017-P-5787 Reference 178 The Pharma Letter_FDA C'tee Raises Concerns Over Merck's Propecia (11-19-97) re Citizen Petition Post- Finasteride Syndrome Foundation Supporting & Related Material Background Material 2017-09-21T04:00:00Z 2017 9     2017-09-21T21:00:11Z   0 0 0900006482b65b75
FDA-2017-P-5787-0181 FDA None FDA-2017-P-5787 Reference 179 The Pharma Letter_Propecia Approved in US for MPB (1-12-98) re Citizen Petition Post- Finasteride Syndrome Foundation Supporting & Related Material Background Material 2017-09-21T04:00:00Z 2017 9     2017-09-21T21:00:15Z   0 0 0900006482b65b76
FDA-2017-P-5787-0086 FDA None FDA-2017-P-5787 Reference 84 Ko_CDER Medical Review_NDA 20-788_P2 (Dec-1997) re Citizen Petition Post- Finasteride Syndrome Foundation Supporting & Related Material Background Material 2017-09-21T04:00:00Z 2017 9     2017-09-21T20:54:00Z   0 0 0900006482b65d81
FDA-2017-P-5787-0121 FDA None FDA-2017-P-5787 Reference 119 Melcangi_CSF Neurosteroid Levels in PFS (JSM 2013) re Citizen Petition Post- Finasteride Syndrome Foundation Supporting & Related Material Background Material 2017-09-21T04:00:00Z 2017 9     2017-09-21T20:56:19Z   0 0 0900006482b65dc2
FDA-2017-P-5787-0128 FDA None FDA-2017-P-5787 Reference 126 Nickel_PROSPECT Study in BPH (Can Med Assoc J 1996)_ re Citizen Petition Post- Finasteride Syndrome Foundation Supporting & Related Material Background Material 2017-09-21T04:00:00Z 2017 9     2017-09-21T20:56:43Z   0 0 0900006482b65afd
FDA-2017-P-5787-0146 FDA None FDA-2017-P-5787 Reference 144 Propecia Selected Safety Information - Not an Antiandrogen (Propecia Website 10-5-08) re Citizen Petition Post- Finasteride Syndrome Foundation Supporting & Related Material Background Material 2017-09-21T04:00:00Z 2017 9     2017-09-21T20:57:55Z   0 0 0900006482b65b28
FDA-2017-P-5787-0003 FDA None FDA-2017-P-5787 Reference 1 Ali_Pharmacovigil of Persistent SD and Suicidal Ideation w Finasteride (Pharmacother 2015) re Citizen Petition Post- Finasteride Syndrome Foundation Supporting & Related Material Background Material 2017-09-21T04:00:00Z 2017 9     2017-09-21T20:44:39Z   0 0 0900006482b650a5
FDA-2017-P-5787-0015 FDA None FDA-2017-P-5787 Reference 13 Basaria_Characteristics of Men w Persistent SD after Finasteride for AGA_supplementary appendix (JCEM 2016) re Citizen Petition Post- Finasteride Syndrome Foundation Supporting & Related Material Background Material 2017-09-21T04:00:00Z 2017 9     2017-09-21T20:45:33Z   0 0 0900006482b658b9
FDA-2017-P-5787-0017 FDA None FDA-2017-P-5787 Reference 15 Belelli_Neurosteroids and the GABA-A Receptor (Nat Rev Neurosci 2005) re Citizen Petition Post- Finasteride Syndrome Foundation Supporting & Related Material Background Material 2017-09-21T04:00:00Z 2017 9     2017-09-21T20:45:39Z   0 0 0900006482b658bb
FDA-2017-P-5787-0032 FDA None FDA-2017-P-5787 Reference 30 Celotti_Steroid Metabolism in the Mammalian Brain (Brain Res Bull 1997) re Citizen Petition Post- Finasteride Syndrome Foundation Supporting & Related Material Background Material 2017-09-21T04:00:00Z 2017 9     2017-09-21T20:50:21Z   0 0 0900006482b658db
FDA-2017-P-5787-0034 FDA None FDA-2017-P-5787 Reference 32 Charmandari_DHT Administration in Children (Horm Res 2001) re Citizen Petition Post- Finasteride Syndrome Foundation Supporting & Related Material Background Material 2017-09-21T04:00:00Z 2017 9     2017-09-21T20:50:28Z   0 0 0900006482b658dd
FDA-2017-P-5787-0162 FDA None FDA-2017-P-5787 Reference 160 Sawaya_Novel Agents for the Treatment of Alopecia (Semin Cut Med Surg 1998) re Citizen Petition Post- Finasteride Syndrome Foundation Supporting & Related Material Background Material 2017-09-21T04:00:00Z 2017 9     2017-09-21T20:59:04Z   0 0 0900006482b65e5d
FDA-2017-P-5787-0169 FDA None FDA-2017-P-5787 Reference 167 Shukla_Finasteride Analysis of Comparative of Pharmacodynamic effects of 1 mg and 5 mg Finasteride Dose_ ID 3046462 (1-Jun-2011) re Citizen Petition Post- Finasteride Syndrome Foundation Supporting & Related Material Background Material 2017-09-21T04:00:00Z 2017 9     2017-09-21T20:59:29Z   0 0 0900006482b65e8a
FDA-2017-P-5787-0053 FDA None FDA-2017-P-5787 Reference 51 Gao_Chemistry and Structural Biology of AR (Chem Rev 2005) re Citizen Petition Post- Finasteride Syndrome Foundation Supporting & Related Material Background Material 2017-09-21T04:00:00Z 2017 9     2017-09-21T20:51:49Z   0 0 0900006482b659f1
FDA-2017-P-5787-0055 FDA None FDA-2017-P-5787 Reference 53 Giatti_Effects of Subchronic Finasteride Rx and Withdrawal in Male Rat Brain (Neuroendocrin 2015) re Citizen Petition Post- Finasteride Syndrome Foundation Supporting & Related Material Background Material 2017-09-21T04:00:00Z 2017 9     2017-09-21T20:51:56Z   0 0 0900006482b659f3
FDA-2017-P-5787-0072 FDA None FDA-2017-P-5787 Reference 70 Ioannidis_Safety Reporting in RCTs (JAMA 2001) re Citizen Petition Post- Finasteride Syndrome Foundation Supporting & Related Material Background Material 2017-09-21T04:00:00Z 2017 9     2017-09-21T20:53:08Z   0 0 0900006482b65a21
FDA-2017-P-5787-0074 FDA None FDA-2017-P-5787 Reference 72 Irwig_Depressive and Suicidal Sx in PFS (J Clin Psych 2012) re Citizen Petition Post- Finasteride Syndrome Foundation Supporting & Related Material Background Material 2017-09-21T04:00:00Z 2017 9     2017-09-21T20:53:15Z   0 0 0900006482b65a23
FDA-2017-P-5787-0096 FDA None FDA-2017-P-5787 Reference 94 Lewis_Effect of Androgen on Penile Tissue (Endocrine 2004) re Citizen Petition Post- Finasteride Syndrome Foundation Supporting & Related Material Background Material 2017-09-21T04:00:00Z 2017 9     2017-09-21T20:54:43Z   0 0 0900006482b65a90
FDA-2017-P-5787-0204 FDA None FDA-2017-P-5787 Reference 202 Zhang_Finasteride and ED in Rat Model (J Sex Med 2012) re Citizen Petition Post- Finasteride Syndrome Foundation Supporting & Related Material Background Material 2017-09-21T04:00:00Z 2017 9     2017-09-21T21:01:45Z   0 0 0900006482b65bae
FDA-2017-P-5787-0140 FDA None FDA-2017-P-5787 Reference 138 Prescriber Update_Post Finasteride Syndrome (New Zealand 29-Apr-2016) re Citizen Petition Post- Finasteride Syndrome Foundation Supporting & Related Material Background Material 2017-09-21T04:00:00Z 2017 9     2017-09-21T20:57:32Z   0 0 0900006482b65e1d
FDA-2017-P-5787-0158 FDA None FDA-2017-P-5787 Reference 156 Romer_Finasteride Inhibits Hippocampal Neurogenesis in Mice (Pharmacopsych 2010) re Citizen Petition Post- Finasteride Syndrome Foundation Supporting & Related Material Background Material 2017-09-21T04:00:00Z 2017 9     2017-09-21T20:58:49Z   0 0 0900006482b65e59
FDA-2017-P-5787-0159 FDA None FDA-2017-P-5787 Reference 157 Ruizeveld de Winter_AR Expression in Human Tissues (J Histochem Cytochem 1991) re Citizen Petition Post- Finasteride Syndrome Foundation Supporting & Related Material Background Material 2017-09-21T04:00:00Z 2017 9     2017-09-21T20:58:53Z   0 0 0900006482b65e5a
FDA-2017-P-5787-0190 FDA None FDA-2017-P-5787 Reference 188 Traish_Glucose, Lipids and SD w Dutasteride for BPH (Horm Mol Biol Clin Invest 2017) re Citizen Petition Post- Finasteride Syndrome Foundation Supporting & Related Material Background Material 2017-09-21T04:00:00Z 2017 9     2017-09-21T21:00:50Z   0 0 0900006482b65ebd
FDA-2017-P-5787-0059 FDA None FDA-2017-P-5787 Reference 57 Gormley_MK-906 and Circulating Androgens (J Clin Endocr Metab 1990) re Citizen Petition Post- Finasteride Syndrome Foundation Supporting & Related Material Background Material 2017-09-21T04:00:00Z 2017 9     2017-09-21T20:52:11Z   0 0 0900006482b65d50
FDA-2017-P-5787-0118 FDA None FDA-2017-P-5787 Reference 116 MedWatch FDA Form 3500_PFSS#8 (28-May-2017) re Citizen Petition Post- Finasteride Syndrome Foundation Supporting & Related Material Background Material 2017-09-21T04:00:00Z 2017 9     2017-09-21T20:56:09Z   0 0 0900006482b65dbf
FDA-2017-P-5787-0105 FDA None FDA-2017-P-5787 Reference 103 MedWatch FDA Form 3500_PFSS#1 continued (24-May-2017) re Citizen Petition Post- Finasteride Syndrome Foundation Supporting & Related Material Background Material 2017-09-21T04:00:00Z 2017 9     2017-09-21T20:55:16Z   0 0 0900006482b65aaf
FDA-2017-P-5787-0132 FDA None FDA-2017-P-5787 Reference 130 Overstreet_Finasteride, Spermatogenesis and Semen Production (J Urol 1999) re Citizen Petition Post- Finasteride Syndrome Foundation Supporting & Related Material Background Material 2017-09-21T04:00:00Z 2017 9     2017-09-21T20:57:00Z   0 0 0900006482b65b01
FDA-2017-P-5787-0151 FDA None FDA-2017-P-5787 Reference 149 Rasmusson_Treating AGA with Finasteride _U.S. Patent # 5,571,817 (5-Nov-1996) re Citizen Petition Post- Finasteride Syndrome Foundation Supporting & Related Material Background Material 2017-09-21T04:00:00Z 2017 9     2017-09-21T20:58:22Z   0 0 0900006482b65b2d
FDA-2017-P-5787-0153 FDA None FDA-2017-P-5787 Reference 151 Rittmaster_Apoptosis of Prostate in Men given Finasteride (JCEM 1996) re Citizen Petition Post- Finasteride Syndrome Foundation Supporting & Related Material Background Material 2017-09-21T04:00:00Z 2017 9     2017-09-21T20:58:29Z   0 0 0900006482b65b2f
FDA-2017-P-5787-0061 FDA None FDA-2017-P-5787 Reference 59 Grino_Phase III Studies of Finasteride for BPH (Eur Urol 1994) re Citizen Petition Post- Finasteride Syndrome Foundation Supporting & Related Material Background Material 2017-09-21T04:00:00Z 2017 9     2017-09-21T20:52:18Z   0 0 0900006482b65d52
FDA-2017-P-5787-0085 FDA None FDA-2017-P-5787 Reference 83 Ko_CDER Medical Review_NDA 20-788_P1 (Dec-1997) re Citizen Petition Post- Finasteride Syndrome Foundation Supporting & Related Material Background Material 2017-09-21T04:00:00Z 2017 9     2017-09-21T20:53:56Z   0 0 0900006482b65d80
FDA-2017-P-5787-0125 FDA None FDA-2017-P-5787 Reference 123 MK-906 Protocol_PLESS Trial (20-Nov-1991) re Citizen Petition Post- Finasteride Syndrome Foundation Supporting & Related Material Background Material 2017-09-21T04:00:00Z 2017 9     2017-09-21T20:56:33Z   0 0 0900006482b65dc6
FDA-2017-P-5787-0005 FDA None FDA-2017-P-5787 Reference 3 Amendments to Propecia Mktg Authorisation (CMDh Apr-2017) re Citizen Petition Post- Finasteride Syndrome Foundation Supporting & Related Material Background Material 2017-09-21T04:00:00Z 2017 9     2017-09-21T20:44:47Z   0 0 0900006482b650a7

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    id TEXT PRIMARY KEY,
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    docket_id TEXT REFERENCES dockets(id),
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CREATE INDEX idx_docs_frnum ON documents(fr_doc_num);
CREATE INDEX idx_docs_comment_end ON documents(comment_end_date) WHERE comment_end_date IS NOT NULL AND withdrawn = 0;