Overview
Lorazepam is a short-acting and rapidly cleared benzodiazepine used commonly as a sedative and anxiolytic. It was developed by DJ Richards, presented and marketed initially by Wyeth Pharmaceuticals in the USA in 1977. The first historic FDA label approval is reported in 1985 by the company Mutual Pharm.
Indication
Lorazepam is FDA-approved for the short-term relief of anxiety symptoms related to anxiety disorders and anxiety associated with depressive symptoms such as anxiety-associated insomnia. It is as well used as an anesthesia premedication in adults to relieve anxiety or to produce sedation/amnesia and for the treatment of status epilepticus. Some off-label indications of lorazepam include rapid tranquilization of an agitated patient, alcohol withdrawal delirium, alcohol withdrawal syndrome, muscle spasms, insomnia, panic disorder, delirium, chemotherapy-associated anticipatory nausea and vomiting, and psychogenic catatonia.
Associated Conditions
- Agitation
- Alcohol Withdrawal Delirium
- Alcohol Withdrawal Syndrome
- Anxiety
- Anxiety Disorders
- Chemotherapy-Induced Nausea and Vomiting
- Delirium
- Insomnia
- Muscle Spasms
- Panic Disorder
- Psychogenic Catatonia
- Status Epilepticus
Clinical Trials
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Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2021/06/11 | Early Phase 1 | Active, not recruiting | |||
2021/01/20 | Phase 2 | Terminated | |||
2020/12/17 | Early Phase 1 | Withdrawn | |||
2020/11/27 | Phase 2 | UNKNOWN | Bambino Gesù Hospital and Research Institute | ||
2020/01/27 | Phase 4 | Active, not recruiting | |||
2019/11/07 | Phase 4 | UNKNOWN | |||
2019/07/02 | Phase 4 | Completed | |||
2019/04/05 | N/A | Completed | |||
2019/02/04 | Phase 1 | Completed | University Hospital, Bonn | ||
2018/12/28 | Phase 4 | Withdrawn |
FDA Drug Approvals
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Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| REMEDYREPACK INC. | 70518-3870 | ORAL | 1 mg in 1 1 | 4/2/2024 | |
| PD-Rx Pharmaceuticals, Inc. | 72789-339 | ORAL | 2 mg in 1 1 | 7/27/2023 | |
| Contract Pharmacy Services-PA | 67046-981 | ORAL | 1 mg in 1 1 | 6/26/2008 | |
| SUN PHARMACEUTICAL INDUSTRIES INC | 63304-772 | ORAL | 0.5 mg in 1 1 | 7/5/2023 | |
| RedPharm Drug, Inc. | 67296-1228 | ORAL | 1 mg in 1 1 | 1/20/2020 | |
| Excellium Pharmaceutical Inc. | 64125-906 | ORAL | 2 mg in 1 1 | 8/23/2012 | |
| NuCare Pharmaceuticals,Inc. | 68071-4918 | ORAL | 1 mg in 1 1 | 2/18/2021 | |
| Hikma Pharmaceuticals USA Inc. | 0641-6001 | INTRAMUSCULAR, INTRAVENOUS | 2.0 mg in 1 mL | 4/7/2023 | |
| Contract Pharmacy Services-PA | 67046-980 | ORAL | 0.5 mg in 1 1 | 6/26/2008 | |
| Asclemed USA, Inc. | 76420-647 | ORAL | 0.5 mg in 1 1 | 11/29/2023 |
EMA Drug Approvals
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Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
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Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
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Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
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Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
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Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| LORAZEPAM SCP lorazepam 1 mg tablet blister pack | 304309 | Medicine | A | 7/22/2019 | |
| Ativan 2.5mg tablets - Export | 336771 | Medicine | A | 5/21/2020 | |
| LORAZE lorazepam 4 mg/1 mL solution for injection ampoule | 352551 | Medicine | A | 3/31/2022 | |
| LORAZEPAM SCP lorazepam 2.5 mg tablet blister pack | 304310 | Medicine | A | 7/22/2019 | |
| LORAZEPAM-AFT lorazepam 4 mg/1 mL solution for injection ampoule | 407852 | Medicine | A | 7/10/2024 | |
| LORAZEPAM-WGR lorazepam 1 mg tablet blister pack | 439654 | Medicine | A | 5/6/2024 | |
| LORAZEPAM LUPIN lorazepam 2.5 mg tablet blister pack | 389602 | Medicine | A | 8/15/2022 | |
| LORAZEPAM VIATRIS lorazepam 2.5 mg tablet blister pack | 304313 | Medicine | A | 7/22/2019 | |
| LORAZEPAM LUPIN lorazepam 1 mg tablet blister pack | 389601 | Medicine | A | 8/15/2022 | |
| ATIVAN Lorazepam 2.5mg tablet blister pack | 10388 | Medicine | A | 7/4/1991 |
Health Canada Drug Approvals
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Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| LORAZEPAM | sanis health inc | 02351080 | Tablet - Oral | 1.0 MG | 6/15/2010 |
| LORAZEPAM INJECTION USP | 02243278 | Solution - Intravenous
,
Intramuscular | 4 MG / ML | 6/6/2001 | |
| LORAZEPAM SUBLINGUAL | aa pharma inc | 02410753 | Tablet - Sublingual | 1 MG | 10/16/2013 |
| ATIVAN SUBL TAB 0.5MG | wyeth ltd. | 00722138 | Tablet - Sublingual | 0.5 MG | 12/31/1987 |
| ATIVAN | 02041472 | Tablet - Sublingual | 2 MG | 12/31/1994 | |
| NTP-LORAZEPAM | teva canada limited | 02347741 | Tablet - Oral | 1.0 MG | N/A |
| LORAZEPAM INJECTION USP | 02438704 | Solution - Intramuscular
,
Intravenous | 2 MG / ML | 11/12/2015 | |
| DOM-LORAZEPAM | dominion pharmacal | 02245784 | Tablet - Oral | .5 MG | 4/25/2002 |
| APO-LORAZEPAM | 00655740 | Tablet - Oral | 0.5 MG | 12/31/1985 | |
| ATIVAN INJECTION LIQ 4MG/ML | wyeth canada | 02041405 | Solution - Intramuscular
,
Intravenous | 4 MG / ML | 12/31/1994 |
CIMA AEMPS Drug Approvals
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Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| LORAZEPAM ARISTO 1 MG COMPRIMIDOS BUCODISPERSABLES EFG | 83683 | COMPRIMIDO BUCODISPERSABLE | Medicamento Sujeto A Prescripción Médica. Psicótropos | Not Commercialized | |
| LORAZEPAM KERN PHARMA 1 mg COMPRIMIDOS EFG | 53555 | COMPRIMIDO | Medicamento Sujeto A Prescripción Médica. Psicótropos | Commercialized | |
| LORAZEPAM ARISTO 2,5 MG COMPRIMIDOS EFG | 83682 | COMPRIMIDO | Medicamento Sujeto A Prescripción Médica. Psicótropos | Not Commercialized | |
| LORAZEPAM NORMOGEN 2 MG COMPRIMIDOS EFG | Laboratorios Normon S.A. | 88966 | COMPRIMIDO | Medicamento Sujeto A Prescripción Médica. Psicótropos | Not Commercialized |
| LORAZEPAM DESGEN 5 mg comprimidos | Laboratorio Generfarma S.L. | 55103 | COMPRIMIDO | Medicamento Sujeto A Prescripción Médica. Psicótropos | Not Commercialized |
| LORAZEPAM NORMON 0,5 MG COMPRIMIDOS EFG | Laboratorios Normon S.A. | 86665 | COMPRIMIDO | Medicamento Sujeto A Prescripción Médica. Psicótropos | Commercialized |
| LORAZEPAM AUROVITAS 1 MG COMPRIMIDOS EFG | Aurovitas Spain, S.A.U. | 90287 | COMPRIMIDO | Medicamento Sujeto A Prescripción Médica. Psicótropos | Not Commercialized |
| LORAZEPAM KERN PHARMA 5 MG COMPRIMIDOS EFG | 81245 | COMPRIMIDO | Medicamento Sujeto A Prescripción Médica. Psicótropos | Commercialized | |
| LORAZEPAM AUROVITAS 0,5 MG COMPRIMIDOS EFG | Aurovitas Spain, S.A.U. | 90286 | COMPRIMIDO | Medicamento Sujeto A Prescripción Médica. Psicótropos | Not Commercialized |
| LORAZEPAM ARISTO 2,5 MG COMPRIMIDOS BUCODISPERSABLES EFG | 83684 | COMPRIMIDO BUCODISPERSABLE | Medicamento Sujeto A Prescripción Médica. Psicótropos | Not Commercialized |
Philippines FDA Drug Approvals
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Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
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Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
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Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Malaysia NPRA approvals found for this drug. | |||||
UK EMC Drug Information
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Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
|---|---|---|---|---|---|
| No UK EMC drug information found for this drug. | |||||
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