Sprout Pharmaceuticals Appeals FDA Decision on NDA for Flibanserin to Treat Hypoactive Sexual Desire Disorder in Premenopausal Women

New Drug Approvals

Flibanserin, girosa
167933-07-5
 cas no

147359-76-0 (monoHCl)

Flibanserin, BIMT-17-BS, BIMT-17
1 – [2 – [4 – [3 – (Trifluoromethyl) phenyl] piperazin-1-yl] ethyl] -2,3-dihydro-1H-benzimidazol-2-one
1-[2-(4-(3-trifluoromethyl-phenyl)piperazin-1-yl)ethyl]-2,3-dihydro-1H-benzimidazol-2-one
C20-H21-F3-N4-O, 390.412, Boehringer Ingelheim (Originator)
  • Bimt 17
  • BIMT 17 BS
  • Bimt-17
  • Flibanserin
  • Girosa
  • UNII-37JK4STR6Z
Boehringer Ingelheim (Originator)
Antidepressants, Disorders of Sexual Function and Reproduction, Treatment of, ENDOCRINE DRUGS, Mood Disorders, Treatment of, PSYCHOPHARMACOLOGIC DRUGS, Treatment of Female Sexual Dysfunction, 5-HT1A Receptor Agonists, 5-HT2A Antagonists
Patents
EP 526434, JP 94509575, US 5576318, WO 9303016.
 WO2010/128516 , US2007/265276
Papers
Pharmaceutical Research, 2002 ,  vol. 19,  3,   pg. 345 – 349
Naunyn-Schmiedeberg’s Archives of Pharmacology, 1995 ,  vol. 352, 3  pg. 283 – 290
Journal of Pharmaceutical and Biomedical Analysis, v.57, 2012 Jan 5, p.104(5)
FLIBANSERIN
…………………….

December 11, 2013 – Sprout Pharmaceuticals today announced that it has received and appealed the Food and Drug Administration’s (FDA) Complete Response Letter (CRL) for flibanserin through the Formal Dispute Resolution process.

Flibanserin is an…

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