| DATE | MEDICATION | NOTES | COMPANY |
| 11/26/03 | Bupropion Extended-Release | Generic version of Wellbutrin SR | Eon |
| 11/25/03 | Risperdal | Change in labeling: removal of references to prolonged QTc interval. Apparently, Janssen has satisfied the FDA that this is not a significant problem with Risperdal. | Janssen |
| 11/24/03 | Fentanyl Transdermal System | Generic version of Duragesic Patch (for pain) | Mylan |
| 10/29/03 | Risperdal Consta | Long-acting depot injection of risperidone | Johnson & Johnson |
| 10/27/03 | Orap (pimozide) | Change in labeling | |
| 09/29/03 | Paroxetine (generic Paxil) | Tentatively Approved | Alphapharm |
| 09/29/03 | Meridia (sibutramine) | Revised the PRECAUTIONS and ADVERSE REACTIONS sections of the package inserts to reflect new info on cardiac side effects | Abbott |
| 09/26/03 | Topiramate (generic Topamax) | Tentatively approved | Ivax |
| 09/24/03 | Gabapentin (generic Neurontin) | First approved generic Neurontin to make it to market | Purepac |
| 09/23/03 | Nefazodone (generic Serzone) | Approved generics from multiple companies | Watson, Mylan, Ranbaxy, Dr. Reddy's, Roxane, Geneva, Teva, Ivax, Eon |
| 09/16/03 | Zoloft (sertraline) | New indication showing efficacy and safety in children | Pfizer |
| 09/12/03 | Topiramate (generic Topamax) | Tentatively approved | Roxane Labs |
| 08/28/03 | Paxil CR (paroxetine) | New indication for Premenstrual dysphoric disorder (PMDD) | GlaxoSmithKline |
| 08/28/03 | Wellbutrin XL (bupropion) | Once-a-day formulation approved (see letter) | GlaxoSmithKline |
| 08/22/03 | Paroxetine (generic Paxil) | Approved (see letter and package insert) | Synthon |
| 08/22/03 | Zonegran (zonisamide) | Two additional dosage strengths (25 mg, 50 mg) were approved (see label) | Dainippon/Elan |
| 08/20/03 | Levitra (vardenafil) | Approved for the treatment of erectile dysfunction [INFO] [LABEL] | Bayer |
| 08/11/03 | Trileptal (oxcarbazepine) | Approved as seizure monotherapy in children (first such approval since 1978) [LABEL] | Novartis |
| 08/07/03 | Gabapentin (generic Neurontin) | Tentative approval (TA) | TEVA (first TA; 3 other companies have "approvable" letters) |
| 07/31/2003 | Paroxetine (generic Paxil) | Approved | Apotex, US agent for Torpharm |
| 07/22/2003 | Zolpidem (generic Ambien) | Tentatively approved | Mylan |
| 07/07/03 | Nefazodone (generic for Serzone) | Tentatively approved | Various 2003 dates for the following companies: Roxane, Geneva, Ranbaxy, IVAX, Dr. Reddy's |
| 06/20/03 | Lamictal (lamotrigine) | New indication approved for "the maintenance treatment of Bipolar I Disorder to delay the time to occurrence of mood episodes (depression, mania, hypomania, mixed episodes) in patients treated for acute mood episodes with standard therapy." See Package Insert. ["Important drug warning" letter] | GlaxoSmithKline |
| 06/13/03 | Effexor and Effexor XR (venlafaxine) | *Not* approved for use in pediatric population | Wyeth-Ayerst |
| 06/10/03 | Lithium carbonate extended-release | Approved 300 mg tabs (generic of Eskalith) [LETTER] [LABEL] | Barr |
| 05/15/2003 | Elavil (amitriptyline) | Elavil tablets are being discontinued. "The remaining inventory of ELAVIL Tablets will be depleted by December 31, 2003. AstraZeneca has no further plans to manufacture ELAVIL." | Astra-Zeneca |
| 04/28/2003 | Pergolide (generic Permax) | Tentatively approved | Ivax |
| 04/28/2003 | Topiramate (generic Topomax) | Tentatively approved | Mylan |
| 05/06/2003 | Mirtazapine (generic Remeron) | 7.5 mg tablet has been applied for to FDA | not specified |
| 03/26/2003 | Emend (aprepitant) | New first-in-class drug, an NK1 (neurokinin-1) antagonist (also called a Substance P antagonist, it is approved for use with a 5HT-3 antagonist for delayed nausea and vomiting associated with chemotherapy. However, it also shows promise as an antidepressant. [Package insert] [FDA Review] | Merck |
| 02/12/03 | Effexor & Effexor XR/venlafaxine | Updated package labeling: Adds new info about hyponatremia (low sodium), bleeding and bruising tendencies, increased cholesterol, fatigue, discontinuation symptoms, low blood cell counts, and "pulmonary eosinophilia". | Wyeth-Ayerst |
| 02/12/03 | Zoloft/sertraline | New approved indication: Social Anxiety Disorder | Pfizer |
| 02/12/03 | Effexor XR/venlafaxine | New approved indication: Social Anxiety Disorder | Wyeth-Ayerst |
| 01/17/03 | Xanax XR/alprazolam [label] | Approved extended-release formulation | Wyeth-Ayerst |
| 01/15/03 | Mirtazapine | Generic for Remeron. Tentatively approved. | Roxane Laboratories |
| 01/15/03 | Nefazodone | Generic for Serzone. Tentatively approved. | Roxane Laboratories; also Eon Labs, Ranbaxy, Mylan, Watson, and Geneva |
| 01/03/03 | Prozac/fluoxetine | New Indication: Major Depressive Disorder (MDD) and Obsessive Compulsive Disorder (OCD) in the pediatric population (7-17 years old) | Lilly |
| 11/26/02 | Strattera/atomoxetine | Selective norepinephrine reuptake inhibitor for ADHD [package insert.pdf] | Lilly |
| 11/15/02 | Abilify/aripiprazole | Atypical antipsychotic for schizophrenia [package insert.pdf] | Otsuka |
| 10/30/02 | Gabapentin | Tentative approval for generic of Neurontin | Purepac |
| 10/28/02 | Nefazodone | Tentative approval for generics of Serzone | Eon, Mylan, and Watson |
| 8/30/02 | Lexapro/escitalopram | Single isomer version of Celexa/citalopram | Forest |
| 07/18/02 | Xyrem (sodium oxybate) | also known as GHB or gamma-hydroxybutyrate, indicated for narcolepsy | Rx Orphan Medical |
| 06/21/02 | Tramadol (Ultram) | Generic Ultram approved | Multiple manufacturers |
| 05/16/02 | Zoloft (sertraline) | Approved for treatment of PMDD (Premenstrual Dysphoric Disorder). Joins other indications for major depression, OCD, PTSD, and panic disorder | Company |
| 04/26/02 | Zolpidem (Ambien) | First generic Ambien gains tentative approval | Par |
| 03/11/02 | Asimia | Tentative approval granted for this brand of paroxetine (Paxil). Synthon and GSK are in patent litigation before it can be released. | Synthon Labs |
| 02/12/02 | Paxil CR (paroxetine) | Time-release 12.5, 25, & 37.5 mg tablets. These have been approved for a few years now, but the company has chosen not to market it. | GlaxoSmithKline |
| 02/11/02 | Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate & Amphetamine Sulfate | Generic version of Adderall | Barr Labs |
| 01/15/02 | Mirtazapine (Generic version of Remeron) | tablets | Teva |
| 2001 | New Drugs Approved for 2001 | http://www.fda.gov/cder/rdmt/ndaaps01cy.htm | FDA |