Overview
Sotalol is a methanesulfonanilide developed in 1960. It was the first of the class III anti arrhythmic drugs. Sotalol was first approved as an oral tablet on 30 October 1992. A racemic mixture of sotalol is currently formulated as a tablet, oral solution, and intravenous injection indicated for life threatening ventricular arrhythmias and maintaining normal sinus rhythm in atrial fibrillation or flutter.
Indication
Sotalol is indicated to treat life threatening ventricular arrhytmias and maintain normal sinus rhythm in patients with atrial fibrillation or flutter. There are also oral solutions and intravenous injections indicated for patients requiring sotalol, but for whom a tablet would not be appropriate.
Associated Conditions
- Sinus Rhythm
- Life-threatening ventricular arrhythmias
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
---|---|---|---|---|---|
2022/06/14 | Phase 4 | UNKNOWN | |||
2022/03/15 | N/A | Completed | |||
2022/02/18 | N/A | Completed | |||
2019/10/16 | N/A | Completed | Samir Saba | ||
2019/03/29 | Phase 4 | UNKNOWN | |||
2019/02/19 | Not Applicable | Completed | Maatschap Cardiologie Zwolle | ||
2019/01/10 | Phase 1 | Completed | |||
2015/12/08 | Phase 3 | Completed | Edgar Jaeggi | ||
2015/01/27 | Phase 4 | Recruiting | |||
2014/11/19 | Not Applicable | UNKNOWN |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
---|---|---|---|---|---|
Carilion Materials Management | 68151-2702 | ORAL | 80 mg in 1 1 | 2/22/2016 | |
Major Pharmaceuticals | 0904-7143 | ORAL | 80 mg in 1 1 | 11/24/2021 | |
Physicians Total Care, Inc. | 54868-5549 | ORAL | 160 mg in 1 1 | 4/23/2012 | |
Apotex Corp. | 60505-0159 | ORAL | 120 mg in 1 1 | 7/5/2023 | |
PD-Rx Pharmaceuticals, Inc. | 72789-138 | ORAL | 120 mg in 1 1 | 2/8/2024 | |
Bayshore Pharmaceuticals LLC | 76385-116 | ORAL | 160 mg in 1 1 | 12/6/2017 | |
Bryant Ranch Prepack | 63629-2422 | ORAL | 80 mg in 1 1 | 2/2/2022 | |
Teva Pharmaceuticals USA, Inc. | 0093-1062 | ORAL | 160 mg in 1 1 | 1/25/2023 | |
Proficient Rx LP | 71205-046 | ORAL | 80 mg in 1 1 | 11/1/2022 | |
Proficient Rx LP | 63187-426 | ORAL | 80 mg in 1 1 | 11/1/2019 |
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 |
---|---|---|---|---|---|
SotaHexal 80mg Tablet | SIN13311P | TABLET, FILM COATED | 80mg | 7/3/2007 | |
APO-SOTALOL TABLET 160 mg | SIN09139P | TABLET | 160 mg | 1/13/1997 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
---|---|---|---|---|---|
No NMPA approvals found for this drug. |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
---|---|---|---|---|---|
No PPB approvals found for this drug. |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
---|---|---|---|---|---|
Sotalol 80mg tablet bottle | 133583 | Medicine | A | 12/11/2006 | |
SOTACOR sotalol hydrochloride 80mg tablet blister pack | 68964 | Medicine | A | 11/16/1999 | |
SOTALOL-STR sotalol hydrochloride 160 mg tablet blister pack | 333530 | Medicine | A | 5/4/2020 | |
SOTALOL DAROB TABLETS 160 mg (BULK) | 404971 | Medicine | A | 2/17/2023 | |
SOTALOL-WGR sotalol hydrochloride 80 mg tablet blister pack | 333533 | Medicine | A | 5/4/2020 | |
SOTACOR sotalol hydrochloride 160mg tablet blister pack | 68966 | Medicine | A | 11/16/1999 | |
Sotalol hydrochloride 160 mg tablet (BULK) | 392518 | Medicine | A | 7/20/2022 | |
APX-SOTALOL sotalol hydrochloride 160 mg tablet blister pack | 333532 | Medicine | A | 5/4/2020 | |
SOLAVERT sotalol hydrochloride 80mg tablet blister pack | 79916 | Medicine | A | 8/22/2001 | |
SOTALOL SANDOZ Sotalol hydrochloride 160mg tablet blister pack | 63724 | Medicine | A | 4/2/1998 |
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
---|---|---|---|---|---|
MYLAN-SOTALOL | Mylan Pharmaceuticals ULC | 02229779 | Tablet - Oral | 160 MG | 10/21/1996 |
MYLAN-SOTALOL | Mylan Pharmaceuticals ULC | 02229778 | Tablet - Oral | 80 MG | 10/21/1996 |
LINSOTALOL -TAB 160MG | linson pharma co. | 02170841 | Tablet - Oral | 160 MG | 12/31/1995 |
LINSOTALOL - TAB 80MG | linson pharma co. | 02170833 | Tablet - Oral | 80 MG | 12/31/1995 |
APO-SOTALOL | 02167794 | Tablet - Oral | 160 MG | 12/31/1995 | |
SOTACOR TAB 80MG | bristol labs division of bristol-myers squibb | 00897272 | Tablet - Oral | 80 MG | 12/31/1993 |
SANDOZ SOTALOL | 02257831 | Tablet - Oral | 80 MG | 9/21/2004 | |
RHOXAL-SOTALOL | rhoxalpharma inc | 02234008 | Tablet - Oral | 80 MG | 12/2/1997 |
NOVO-SOTALOL TAB 80MG | novopharm limited | 02231181 | Tablet - Oral | 80 MG | 5/13/1997 |
RIVA-SOTALOL | laboratoire riva inc. | 02272164 | Tablet - Oral | 80 MG | 6/4/2010 |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
---|---|---|---|---|---|
No CIMA AEMPS (Spain) approvals found for this drug. |
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No Philippines FDA approvals found for this drug. |
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No Saudi SFDA approvals found for this drug. |
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No Malaysia NPRA approvals found for this drug. |
UK EMC Drug Information
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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