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.) 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