Overview
Fosamprenavir is a prodrug of amprenavir, an inhibitor of human immunodeficiency virus (HIV) protease.
Background
Fosamprenavir is a prodrug of amprenavir, an inhibitor of human immunodeficiency virus (HIV) protease.
Indication
Indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (HIV-1) infection, as well as postexposure prophylaxis of HIV infection in individuals who have had occupational or nonoccupational exposure to potentially infectious body fluids of a person known to be infected with HIV when that exposure represents a substantial risk for HIV transmission. The use of fosamprenavir is pending revision due to a potential association between the drug and myocardial infarction and dyslipidemia in HIV infected adults.
Associated Conditions
- Human Immunodeficiency Virus Type 1 (HIV-1) Infection
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2024/11/25 | Phase 2 | Not yet recruiting | |||
2020/05/12 | Phase 2 | Not yet recruiting | |||
2010/10/18 | Phase 4 | Completed | |||
2010/09/24 | Phase 1 | Completed | |||
2009/01/06 | Phase 1 | Completed | |||
2008/12/04 | Not Applicable | Completed | Garden State Infectious Disease Associates, PA | ||
2008/10/17 | Phase 1 | Completed | Tibotec BVBA | ||
2008/10/02 | Phase 2 | Completed | Garden State Infectious Disease Associates, PA | ||
2008/02/14 | Not Applicable | Completed | Garden State Infectious Disease Associates, PA | ||
2007/06/01 | Phase 1 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| State of Florida DOH Central Pharmacy | 53808-1010 | ORAL | 700 mg in 1 1 | 1/10/2015 | |
| State of Florida DOH Central Pharmacy | 53808-0281 | ORAL | 700 mg in 1 1 | 4/14/2010 | |
| Sun Pharmaceutical Industries, Inc. | 63304-583 | ORAL | 700 mg in 1 1 | 12/2/2019 | |
| ViiV Healthcare Company | 49702-208 | ORAL | 50 mg in 1 mL | 12/1/2017 | |
| ViiV Healthcare Company | 49702-207 | ORAL | 700 mg in 1 1 | 12/1/2017 | |
| Mylan Pharmaceuticals Inc. | 0378-3520 | ORAL | 700 mg in 1 1 | 7/15/2019 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 7/12/2004 | ||
Authorised | 7/12/2004 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
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 |
|---|---|---|---|---|---|
| TELZIR fosamprenavir 700mg (as calcium) tablet | 101604 | Medicine | A | 5/27/2004 |