Table 1.
New Indications and Product Entry for SSRIs
| SSRI | Initial FDA Approval | Generic Entry | New Indication | New Formulation Entry |
|---|---|---|---|---|
| Prozac* | 12/87 | 8/01 | PMDD 7/00 | Prozac Weekly 3/01 |
| Panic Disorder 7/02 | ||||
| Zoloft | 12/91 | 6/06 | Panic Disorder 7/97 | -- |
| PTSD 12/99 | ||||
| PMDD 5/02 | ||||
| SAD 2/03 | ||||
| Paxil | 12/92 | 6/03 | SAD 5/99 | Paxil CR 4/02 |
| GAD 4/01 | ||||
| Celexa | 7/98 | 10/04 | -- | Lexapro 8/02 |
PMDD=premenstrual dysphoric disorder; PTSD=post-traumatic stress disorder; SAD=social anxiety disorder; GAD=generalized anxiety disorder
*
Prozac also has an indication for use in pediatric populations.
Data sources: FDA Orange Book of Approved Therapeutic Equivalents; FDA New and Generic Drug Approvals, http://www.fda.gov/cder/approval/index.htm; FDA Safety Related Drug Labeling Changes,http://www.fda.gov/medwatch/