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withdrawn,object_id FDA-2017-P-5787-0205,FDA,FDA-2017-P-5787,Table of Contents re Citizen Petition Post- Finasteride Syndrome Foundation,Supporting & Related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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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 FDA-2017-P-5787-0016,FDA,FDA-2017-P-5787,Reference 14 Becker_Plaintiffs Motion to Amend PPO (20-Jun-2016) re Citizen Petition Post- Finasteride Syndrome Foundation,Supporting & Related Material,Background Material,2017-09-21T04:00:00Z,2017,9,,,2017-09-21T20:45:36Z,,0,0,0900006482b658ba FDA-2017-P-5787-0100,FDA,FDA-2017-P-5787,Reference 98 Majewska_Steroid Metabolites and Barbituate-Like Modulation of GABA Receptor (Science 1986) re Citizen Petition Post- Finasteride Syndrome Foundation,Supporting & Related Material,Background Material,2017-09-21T04:00:00Z,2017,9,,,2017-09-21T20:54:58Z,,0,0,0900006482b65aaa FDA-2017-P-5787-0149,FDA,FDA-2017-P-5787,"Reference 147 Rasmusson_4-Aza substituted 5-Alpha Reductase Inhibitors_U.S. Patent # 4,377,584 (22-Mar-1983) re Citizen Petition Post- Finasteride Syndrome Foundation",Supporting & Related Material,Background Material,2017-09-21T04:00:00Z,2017,9,,,2017-09-21T20:58:06Z,,0,0,0900006482b65b2b FDA-2017-P-5787-0031,FDA,FDA-2017-P-5787,Reference 29 Cauci_AR Polymorphisms in PFS (Sex Med 2016) re Citizen Petition Post- Finasteride Syndrome Foundation,Supporting & Related Material,Background Material,2017-09-21T04:00:00Z,2017,9,,,2017-09-21T20:50:16Z,,0,0,0900006482b658da FDA-2017-P-5787-0174,FDA,FDA-2017-P-5787,Reference 172 Steger_Sertoli cells in Human Testis Pathology (Hum Reprod 1999) re Citizen Petition Post- Finasteride Syndrome Foundation,Supporting & Related Material,Background Material,2017-09-21T04:00:00Z,2017,9,,,2017-09-21T20:59:50Z,,0,0,0900006482b65e8f FDA-2017-P-5787-0027,FDA,FDA-2017-P-5787,Reference 25 Caruso_Neuroactive Steroids in PFS Pts (J Ster Biochem Mol Biol 2014) re Citizen Petition Post- Finasteride Syndrome Foundation,Supporting & Related Material,Background Material,2017-09-21T04:00:00Z,2017,9,,,2017-09-21T20:49:55Z,,0,0,0900006482b65926 FDA-2017-P-5787-0038,FDA,FDA-2017-P-5787,Reference 36 Corradi_AR Expression in Gerbil Prostate after 5ARI (Microsc Res Tech 2009) re Citizen Petition Post- Finasteride Syndrome Foundation,Supporting & Related Material,Background Material,2017-09-21T04:00:00Z,2017,9,,,2017-09-21T20:50:41Z,,0,0,0900006482b659c2 FDA-2017-P-5787-0042,FDA,FDA-2017-P-5787,Reference 40 Dermatol Ophthal Drug Advisory Committee Mtg No. 48_CDER (13-Nov-97) re Citizen Petition Post- Finasteride Syndrome Foundation,Supporting & Related Material,Background Material,2017-09-21T04:00:00Z,2017,9,,,2017-09-21T20:50:58Z,,0,0,0900006482b659c6 FDA-2017-P-5787-0050,FDA,FDA-2017-P-5787,Reference 48 Eicheler_Localization of 5AR2 in Androgen and Non-Target Human Tissues (J Histochem Cytochem 1994) re Citizen Petition Post- Finasteride Syndrome Foundation,Supporting & Related Material,Background Material,2017-09-21T04:00:00Z,2017,9,,,2017-09-21T20:51:39Z,,0,0,0900006482b659ee FDA-2017-P-5787-0056,FDA,FDA-2017-P-5787,Reference 54 Gisleskog_DHT Turnover w Irreversible 5ARIs (Clin Pharmacol Ther 1998) re Citizen Petition Post- Finasteride Syndrome Foundation,Supporting & Related Material,Background Material,2017-09-21T04:00:00Z,2017,9,,,2017-09-21T20:51:59Z,,0,0,0900006482b659f4 FDA-2017-P-5787-0073,FDA,FDA-2017-P-5787,Reference 71 Irwig_Androgen and Semen Parameters in PFS Pts (JAMA Derm 2014) re Citizen Petition Post- Finasteride Syndrome Foundation,Supporting & Related Material,Background Material,2017-09-21T04:00:00Z,2017,9,,,2017-09-21T20:53:12Z,,0,0,0900006482b65a22 FDA-2017-P-5787-0203,FDA,FDA-2017-P-5787,"Reference 201 Zhang_EF, Apoptosis and Autophagy w Long-term Finasteride to Rats (Urol 2013) re Citizen Petition Post- Finasteride Syndrome Foundation",Supporting & Related Material,Background Material,2017-09-21T04:00:00Z,2017,9,,,2017-09-21T21:01:41Z,,0,0,0900006482b65bad FDA-2017-P-5787-0135,FDA,FDA-2017-P-5787,Reference 133 Payne_Formation of DHT in Human Testis (JCEM 1973) re Citizen Petition Post- Finasteride Syndrome Foundation,Supporting & Related Material,Background Material,2017-09-21T04:00:00Z,2017,9,,,2017-09-21T20:57:11Z,,0,0,0900006482b65e18 FDA-2017-P-5787-0136,FDA,FDA-2017-P-5787,Reference 134 Pharmaceutical Safety Assessment_Finasteride 1 mg_English Translation (Korean Ministry Drug Safety Jul-2017) re Citizen Petition Post- Finasteride Syndrome Foundation,Supporting & Related Material,Background Material,2017-09-21T04:00:00Z,2017,9,,,2017-09-21T20:57:14Z,,0,0,0900006482b65e19 FDA-2017-P-5787-0138,FDA,FDA-2017-P-5787,Reference 136 Poletti_5AR2 and AR Expression GnRH Cells (J Neuroendocrin 2001) re Citizen Petition Post- Finasteride Syndrome Foundation,Supporting & Related Material,Background Material,2017-09-21T04:00:00Z,2017,9,,,2017-09-21T20:57:23Z,,0,0,0900006482b65e1b FDA-2017-P-5787-0155,FDA,FDA-2017-P-5787,Reference 153 Rittmaster_Finasteride (NEJM 1994) re Citizen Petition Post- Finasteride Syndrome Foundation,Supporting & Related Material,Background Material,2017-09-21T04:00:00Z,2017,9,,,2017-09-21T20:58:38Z,,0,0,0900006482b65e56 FDA-2017-P-5787-0189,FDA,FDA-2017-P-5787,Reference 187 Traish_Finasteride Increases ED Severity and Decreases T in BPH (Horm Mol Biol Clin Invest 2015) re Citizen Petition Post- Finasteride Syndrome Foundation,Supporting & Related Material,Background Material,2017-09-21T04:00:00Z,2017,9,,,2017-09-21T21:00:47Z,,0,0,0900006482b65ebc FDA-2017-P-5787-0043,FDA,FDA-2017-P-5787,Reference 41 Deslypere_T and DHT Interaction w AR (Molec Cell Endocrinol 1992) re Citizen Petition Post- Finasteride Syndrome Foundation,Supporting & Related Material,Background Material,2017-09-21T04:00:00Z,2017,9,,,2017-09-21T20:51:02Z,,0,0,0900006482b659c7 FDA-2017-P-5787-0049,FDA,FDA-2017-P-5787,Reference 47 Dusková_Finasteride Rx for BPH and Neurosteroid Formation (Prag Med Rep 2009) re Citizen Petition Post- Finasteride Syndrome Foundation,Supporting & Related Material,Background Material,2017-09-21T04:00:00Z,2017,9,,,2017-09-21T20:51:35Z,,0,0,0900006482b659ed FDA-2017-P-5787-0051,FDA,FDA-2017-P-5787,Reference 49 Fisher_Genetic 5AR2 Deficiency and Reduction of Cortisol and T (JCEM 1978) re Citizen Petition Post- Finasteride Syndrome Foundation,Supporting & Related Material,Background Material,2017-09-21T04:00:00Z,2017,9,,,2017-09-21T20:51:42Z,,0,0,0900006482b659ef FDA-2017-P-5787-0091,FDA,FDA-2017-P-5787,Reference 89 Kuhn_Percutaneous DHT and Pituitary-Testicular Axis (JCEM 1984) re Citizen Petition Post- Finasteride Syndrome Foundation,Supporting & Related Material,Background Material,2017-09-21T04:00:00Z,2017,9,,,2017-09-21T20:54:26Z,,0,0,0900006482b65a8b FDA-2017-P-5787-0092,FDA,FDA-2017-P-5787,Reference 90 La Marra_Hormone Profile in PFS (Amer J Path Suppl 2012) re Citizen Petition Post- Finasteride Syndrome Foundation,Supporting & Related Material,Background Material,2017-09-21T04:00:00Z,2017,9,,,2017-09-21T20:54:29Z,,0,0,0900006482b65a8c