Overview
Mirtazapine is a tetracyclic piperazino-azepine antidepressant agent that was initially approved for the treatment of major depressive disorder (MDD) in the Netherlands in 1994. This drug was first manufactured by Organon Inc., and received FDA approval in 1997 for the treatment of major depressive disorder. The effects of this drug may be observed as early as 1 week after beginning therapy. In addition to its beneficial effects in depression, mirtazapine has been reported to be efficacious in the off-label management of various other conditions. It may improve the symptoms of neurological disorders, reverse weight loss caused by medical conditions, improve sleep, and prevent nausea and vomiting after surgery.
Indication
This drug is indicated for the treatment of major depressive disorder and its associated symptoms. Mirtazapine has been used off-label for a variety of conditions including panic disorder, generalized anxiety disorder, dysthymia, tension headaches, hot flushes, post-traumatic stress disorder (PTSD), sleep disorders, substance abuse disorders, and sexual disorders, among others.
Associated Conditions
- Cancer Pain
- Depression
- Fibromyalgia
- Generalized Anxiety Disorder
- Hot Flashes
- Insomnia
- Major Depressive Disorder (MDD)
- Obsessive Compulsive Disorder (OCD)
- Panic Disorder
- Persistent Depressive Disorder (Dysthymia)
- Post Operative Nausea and Vomiting (PONV)
- Poststroke depression
- Sleep disorders and disturbances
- Substance Abuse Disorders
- Tension Headache
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2024/11/12 | Early Phase 1 | Recruiting | |||
2024/11/08 | Not Applicable | Completed | |||
2024/07/31 | Phase 2 | Recruiting | Leila Dargahi. PharmD PhD | ||
2024/07/12 | Early Phase 1 | Active, not recruiting | |||
2024/03/21 | Phase 2 | Recruiting | |||
2024/03/13 | Phase 2 | Recruiting | |||
2024/01/19 | Phase 1 | Recruiting | |||
2023/08/07 | Phase 4 | Completed | |||
2022/07/11 | Phase 1 | Withdrawn | |||
2022/05/18 | Phase 2 | UNKNOWN | Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| State of Florida DOH Central Pharmacy | 53808-0482 | ORAL | 15 mg in 1 1 | 8/6/2010 | |
| Proficient Rx LP | 63187-206 | ORAL | 15 mg in 1 1 | 10/1/2022 | |
| Aphena Pharma Solutions - Tennessee, LLC | 71610-717 | ORAL | 15 mg in 1 1 | 6/29/2023 | |
| Sun Pharmaceutical Industries, Inc. | 57664-510 | ORAL | 7.5 mg in 1 1 | 11/30/2021 | |
| Bryant Ranch Prepack | 71335-1332 | ORAL | 45 mg in 1 1 | 2/1/2024 | |
| Sun Pharmaceutical Industries, Inc. | 57664-500 | ORAL | 30 mg in 1 1 | 11/30/2021 | |
| Physicians Total Care, Inc. | 54868-4848 | ORAL | 15 mg in 1 1 | 2/17/2012 | |
| Contract Pharmacy Services-PA | 67046-319 | ORAL | 30 mg in 1 1 | 6/25/2020 | |
| Prasco Laboratories | 66993-607 | ORAL | 15 mg in 1 1 | 2/1/2023 | |
| REMEDYREPACK INC. | 70518-2819 | ORAL | 7.5 mg in 1 1 | 3/6/2024 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| Mirtazapine Sandoz Orodispersible Tablets 15mg | SIN13643P | TABLET, ORALLY DISINTEGRATING | 15.0mg | 5/4/2009 | |
| REMERON SOLTAB 30 mg | SIN12527P | TABLET | 30 mg | 3/25/2004 | |
| APO-MIRTAZAPINE TABLET 30MG | SIN14012P | TABLET, FILM COATED | 30 mg | 9/9/2011 | |
| Mirtazapine Sandoz Orodispersible Tablets 30mg | SIN13644P | TABLET, ORALLY DISINTEGRATING | 30.0mg | 5/4/2009 | |
| REMERON SOLTAB 15 mg | SIN12526P | TABLET | 15 mg | 3/25/2004 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Mirtazapine Tablets | 国药准字HJ20250045 | 化学药品 | 片剂 | 4/15/2025 | |
| Mirtazapine Tablets | 国药准字HJ20250044 | 化学药品 | 片剂 | 4/15/2025 | |
| Mirtazapine Tablets | 国药准字HJ20181173 | 化学药品 | 片剂 | 7/29/2022 | |
| Mirtazapine Tablets | 国药准字HJ20150540 | 化学药品 | 片剂 | 11/30/2023 | |
| Mirtazapine Tablets | 国药准字HJ20140031 | 化学药品 | 片剂 | 11/30/2023 | |
| Mirtazapine Tablets | 国药准字HJ20181172 | 化学药品 | 片剂 | 7/29/2022 | |
| Mirtazapine Tablets | 国药准字H20100103 | 化学药品 | 片剂 | 6/24/2020 | |
| Mirtazapine Tablets | 国药准字H20184125 | 化学药品 | 片剂 | 6/21/2021 | |
| Mirtazapine Tablets | 国药准字H20041656 | 化学药品 | 片剂 | 6/24/2020 | |
| Mirtazapine Tablets | 国药准字HJ20220079 | 化学药品 | 片剂 | 10/11/2022 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| REMERON SOLTAB ORODISPERSIBLE TAB 15MG | N/A | N/A | N/A | 7/8/2004 |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| Mirtazapine tablet 30 mg bottle | 202228 | Medicine | A | 10/25/2012 | |
| MIRTAZAPINE-RJIC ODT mirtazapine 45 mg orally disintegrating tablet blister pack | 421098 | Medicine | A | 1/17/2024 | |
| APO-MIRTAZAPINE mirtazapine 30 mg tablet bottle | 127677 | Medicine | A | 8/14/2007 | |
| BLOOMS THE CHEMIST MIRTAZAPINE mirtazapine 15mg tablets blister pack | 394004 | Medicine | A | 12/23/2022 | |
| MIRTAZAPINE-DWRN ODT mirtazapine 45 mg orally disintegrating tablet blister pack | 421151 | Medicine | A | 1/17/2024 | |
| MIRTAZAPINE-WGR mirtazapine 45 mg tablets blister pack | 420952 | Medicine | A | 2/16/2024 | |
| Mirtazapine Tablets 15mg Bulk | 117777 | Medicine | A | 3/31/2005 | |
| Mirtazapine tablet 15 mg bottle | 202282 | Medicine | A | 10/25/2012 | |
| MIRTAZAPINE SANDOZ mirtazapine 15mg tablets bottle | 117165 | Medicine | A | 6/19/2006 | |
| MIRTANZA ODT mirtazapine 15 mg orally disintegrating tablet blister pack | 183404 | Medicine | A | 1/25/2012 |
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