In 2017, the U.S.
Food and Drug Administration accepted Sunovion's
New Drug Application (NDA) for review for the treatment of ADHD;[7] however, the NDA was ultimately rejected citing the need for additional studies to determine efficacy and tolerability.[8][9][10] In July 2019, Sunovion’s NDA for the treatment of BED was accepted with an expected action date of May 2020.[11] In May 2020, Sunovion halted its drug development program for dasotraline, withdrawing both NDAs for ADHD and BED.[12]
^Ziegler L, Küffer G, Euler E, Wilhelm K (August 1990). "[Arthrographic imaging of ganglions of the hand]" [Arthrographic imaging of ganglions of the hand]. RöFo (in German). 153 (2): 143–6.
doi:
10.1055/s-2008-1033352.
PMID2168068.
S2CID260312446.
^Guiard B, Chenu F, El Mansari M, Blier P (2009). "P.1.c.059 Electrophysiological properties of the triple reuptake inhibitor SEP 225289 on monoaminergic neurons". European Neuropsychopharmacology. 19: S285.
doi:
10.1016/S0924-977X(09)70419-5.
S2CID54263757.
US application 2007203111, Shao L, Wang F, Malcolm SC, Hewitt MC, Bush LR, Ma J, Varney MA, Campbell U, Engel SR, Hardy LW, Koch P, Campbell JE, "Cycloalkylamines as monoamine reuptake inhibitors", published 2007-08-30, assigned to Sepracor Inc.
Asymmetry Patent
US patent 7129378, Han X, Krishnamurthy D, Senanayake CH, Lu Z-H, "Method of preparing amine stereoisomers", published 2005-07-28, assigned to Apsinterm LLC
In 2017, the U.S.
Food and Drug Administration accepted Sunovion's
New Drug Application (NDA) for review for the treatment of ADHD;[7] however, the NDA was ultimately rejected citing the need for additional studies to determine efficacy and tolerability.[8][9][10] In July 2019, Sunovion’s NDA for the treatment of BED was accepted with an expected action date of May 2020.[11] In May 2020, Sunovion halted its drug development program for dasotraline, withdrawing both NDAs for ADHD and BED.[12]
^Ziegler L, Küffer G, Euler E, Wilhelm K (August 1990). "[Arthrographic imaging of ganglions of the hand]" [Arthrographic imaging of ganglions of the hand]. RöFo (in German). 153 (2): 143–6.
doi:
10.1055/s-2008-1033352.
PMID2168068.
S2CID260312446.
^Guiard B, Chenu F, El Mansari M, Blier P (2009). "P.1.c.059 Electrophysiological properties of the triple reuptake inhibitor SEP 225289 on monoaminergic neurons". European Neuropsychopharmacology. 19: S285.
doi:
10.1016/S0924-977X(09)70419-5.
S2CID54263757.
US application 2007203111, Shao L, Wang F, Malcolm SC, Hewitt MC, Bush LR, Ma J, Varney MA, Campbell U, Engel SR, Hardy LW, Koch P, Campbell JE, "Cycloalkylamines as monoamine reuptake inhibitors", published 2007-08-30, assigned to Sepracor Inc.
Asymmetry Patent
US patent 7129378, Han X, Krishnamurthy D, Senanayake CH, Lu Z-H, "Method of preparing amine stereoisomers", published 2005-07-28, assigned to Apsinterm LLC