Table 1. Psychotropic new chemical entities approved in the United States, 1963-1997

  Generic                  Trade                             NDA          NDA        NDA Review

  Name                     Name         Company              Submitted    Approved   Time (mos.)


Antianxiety

  Diazepam                 Valium       Roche                12/15/61     11/15/63      23.0

  Tybamate                 Solacen      Wallace              06/11/63     03/10/65      21.0

  Oxazepam                 Serax        Wyeth                01/13/64     06/04/65      16.7

  Clorazepate dipotassium  Tranxene     Abbott               11/09/71     06/23/72       7.5

  Prazepam                 Verstran     Warner‑Lambert       12/29/72     12/14/76      47.5

  Lorazepam                Ativan       Wyeth                10/08/75     09/30/77      23.8

  Halazepam                Paxipam      Schering Plough      05/13/75     09/24/81      76.4

  Alprazolam               Xanax        Upjohn               03/02/79     10/16/81      31.5

  Buspirone HCl            Buspar       Bristol Myers        12/15/82     09/29/86      45.5

Antidepressant

  Pargyline HCl            Eutonyl      Abbott               03/07/62     02/14/63      11.3

  Nortriptyline HCl        Aventyl      Lilly                06/03/63     11/06/64      17.1

  Desipramine HCl          Norpramin    Merrell              04/09/63     11/20/64      19.4

  Protriptyline HCl        Vivactil     Merck                02/25/64     09/27/67      43.0

  Doxepin HCl              Sinequan     Pfizer               07/05/68     09/23/69      14.6

  Trimipramine maleate     Surmontil    Ives                 06/20/68     06/12/79     131.7

  Amoxapine                Asendin      Lederle              04/14/77     09/22/80      41.3

  Maprotiline HCl          Ludiomil     Ciba‑Geigy           11/01/73     12/01/80      85.0

  Trazodone                Desyrel      Mead Johnson         10/11/78     12/21/81      38.3

  Nomifensine maleate      Merital      Hoechst              12/28/78     12/31/84      72.1

  Bupropion HCl            Wellbutrin   Burroughs Wellcome   12/23/81     12/30/85      48.2

  Fluoxetine HCl           Prozac       Lilly                09/06/83     12/29/87      51.7

  Clomipramine             Anafranil    Ciba‑Geigy           06/16/89     12/29/89       6.4

  Sertralline HCl          Zoloft       Pfizer               04/13/88     12/30/91      44.6

  Paroxetine HCl           Paxil        Smithkline Beecham   11/20/89     12/29/92      37.3

  Venlafaxine HCl          Effexor      Wyeth-Ayerst         04/26/91     12/28/93      32.1

  Nefazodone HCl           Serzone      Bristol-Myers Squibb 09/06/91     12/22/94      39.5

  Mirtazapine              Remeron      Organon              01/30/95     06/14/96      16.5

Antipsychotic

  Carphenazine maleate     Proketazine  Wyeth                01/30/61     01/29/63      24.0

  Haloperidol              Haldol       McNeil               12/17/63     04/12/67      39.8

  Thiothixene              Navane       Pfizer               11/17/66     07/24/67       8.2

  Butaperazine maleate     Repoise      Robins               05/05/64     09/26/67      40.7

  Piperacetazine           Quide        Dow                  05/29/62     02/03/69      80.2

  Mesoridazine             Serentil     Sandoz               04/30/68     02/27/70      21.9

  Lithium carbonate        Eskalith     Smithkline French    05/09/69     04/06/70      10.9

  Molindone HCl            Moban        Du Pont              11/11/71     01/18/74      26.3

  Loxapine succinate       Loxitane     Lederle              09/25/73     02/25/75      17.0

  Pimozide                 Orap         McNeil               04/06/73     07/31/84     135.8

  Clozapine                Clozaril     Sandoz               09/01/87     09/26/89      24.8

  Risperidone              Risperdal    Janssen              04/15/92     12/29/93      20.5

  Olanzapine               Zyprexa      Lilly                09/22/95     09/30/96      12.3

  Quetiapine fumarate      Seroquel     Zeneca               07/29/96     09/26/97      13.9

Sedative/Hypnotic

  Flurazepam HCl           Dalmene      Roche                11/20/67     04/07/70      28.6

  Triclofos sodium         Triclos      Merrell              08/05/68     03/22/72      43.5

  Temazepam                Restoril     Sandoz               06/21/78     02/27/81      32.3

  Etomidate                Amidate      Abbott               11/21/78     09/07/82      45.5

  Triazolam                Halcion      Upjohn               05/11/76     11/15/82      78.2

  Midazolam HCl            Versed       Roche                12/15/82     12/20/85      36.2

  Quazepam                 Dormalin     Schering             04/09/82     12/27/85      44.6

  Estazolam                Proscom      Abbott               12/19/83     12/26/90      84.2

  Zolpidem tartrate        Ambien       Lorex                01/30/89     12/16/92      46.5

Miscellaneous

  Pemoline                 Cylert       Abbott               11/25/68     01/27/75      74.1

 

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published 2000