Overview
Oseltamivir (marketed as the product TamifluⓇ), is an antiviral neuraminidase inhibitor used for the treatment and prophylaxis of infection with influenza viruses A (including pandemic H1N1) and B. Oseltamivir exerts its antiviral activity by inhibiting the activity of the viral neuraminidase enzyme found on the surface of the virus, which prevents budding from the host cell, viral replication, and infectivity. The clinical benefit of use of oseltamivir is greatest when administered within 48 hours of the onset of influenza symptoms since effectiveness decreases significantly after that point in time; there is generally no benefit in use beyond 48 hours for healthy, low-risk individuals as influenza is a self-limiting illness. However, antiviral treatment might be beneficial when initiated after 48 hours for patients with severe, complicated or progressive illness or for hospitalized patients. According to the CDC, data from clinical trials and observational studies have demonstrated that early antiviral treatment can shorten the duration of fever and illness symptoms, and may reduce the risk of some complications (including pneumonia and respiratory failure). They recommend the use of oseltamivir in people with a higher risk of developing complications including children younger than 2 years, people over 65 years, people with some chronic conditions or immunosuppression, pregnant women, residents of long term care facilities, and indigenous communities for example. The benefits of oseltamivir use are controversial; a 2014 Cochrane Review of the evidence found that oseltamivir treatment had limited benefit. The authors concluded that oseltamivir use in healthy adults had small, non-specific effects on symptoms (where the time to first alleviation of symptoms was only reduced from 7 to 6.3 days), it had no effect on hospitalizations, and that there was no evidence for any reductions in complications of influenza such as pneumonia. Due to the risk of adverse effects such as nausea, vomiting, psychiatric effects and renal adverse events in adults and vomiting in children, the harms are generally considered to outweigh the small clinical benefit of use of oseltamivir. Notably, in 2017, the World Health Organization downgraded oseltamivir from its essential medicines list from a "core" drug to a "complementary" drug, due to limited cost-effectiveness. Yearly vaccination with the influenza vaccine is still considered the best preventative measure.
Background
Oseltamivir (marketed as the product TamifluⓇ), is an antiviral neuraminidase inhibitor used for the treatment and prophylaxis of infection with influenza viruses A (including pandemic H1N1) and B. Oseltamivir exerts its antiviral activity by inhibiting the activity of the viral neuraminidase enzyme found on the surface of the virus, which prevents budding from the host cell, viral replication, and infectivity. The clinical benefit of use of oseltamivir is greatest when administered within 48 hours of the onset of influenza symptoms since effectiveness decreases significantly after that point in time; there is generally no benefit in use beyond 48 hours for healthy, low-risk individuals as influenza is a self-limiting illness. However, antiviral treatment might be beneficial when initiated after 48 hours for patients with severe, complicated or progressive illness or for hospitalized patients. According to the CDC, data from clinical trials and observational studies have demonstrated that early antiviral treatment can shorten the duration of fever and illness symptoms, and may reduce the risk of some complications (including pneumonia and respiratory failure). They recommend the use of oseltamivir in people with a higher risk of developing complications including children younger than 2 years, people over 65 years, people with some chronic conditions or immunosuppression, pregnant women, residents of long term care facilities, and indigenous communities for example. The benefits of oseltamivir use are controversial; a 2014 Cochrane Review of the evidence found that oseltamivir treatment had limited benefit. The authors concluded that oseltamivir use in healthy adults had small, non-specific effects on symptoms (where the time to first alleviation of symptoms was only reduced from 7 to 6.3 days), it had no effect on hospitalizations, and that there was no evidence for any reductions in complications of influenza such as pneumonia. Due to the risk of adverse effects such as nausea, vomiting, psychiatric effects and renal adverse events in adults and vomiting in children, the harms are generally considered to outweigh the small clinical benefit of use of oseltamivir. Notably, in 2017, the World Health Organization downgraded oseltamivir from its essential medicines list from a "core" drug to a "complementary" drug, due to limited cost-effectiveness. Yearly vaccination with the influenza vaccine is still considered the best preventative measure.
Indication
According to FDA prescribing information, oseltamivir is indicated for the treatment of acute, uncomplicated illness due to influenza A and B infection in patients 2 weeks of age and older who have been symptomatic for no more than 48 hours . In particular, this agent is indicated in adults and children including full-term neonates who present with symptoms typical of influenza when influenza virus is circulating in the community. Efficacy has been demonstrated when treatment is initiated within two days of the first onset of symptoms. Oseltamivir is also indicated for the prophylaxis of influenza in patients one year and older . Specifically, post-exposure prevention in individuals one year of age or older following contact with a clinically diagnosed influenza case when influenza virus is circulating in the community qualifies for such prophylactic therapy. Oseltamivir would only be indicated for post-exposure prevention of influenza in infants less than 1 year of age during a pandemic influenza outbreak.
Associated Conditions
- Flu caused by Influenza
- Influenza A Virus Infection
- Influenza A, Influenza B
- Influenza Type B
Clinical Trials
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Title | Posted | Study ID | Phase | Status | Sponsor |
---|---|---|---|---|---|
2021/10/19 | Phase 1 | Completed | |||
2021/08/19 | Phase 4 | Active, not recruiting | |||
2021/08/17 | Not Applicable | UNKNOWN | |||
2021/01/15 | Phase 2 | Recruiting | |||
2020/12/24 | Phase 3 | Completed | Guangdong Raynovent Biotech Co., Ltd | ||
2020/12/24 | Phase 4 | UNKNOWN | |||
2020/09/22 | Phase 3 | UNKNOWN | |||
2020/09/02 | Phase 4 | Completed | |||
2020/08/18 | Phase 2 | Completed | |||
2020/07/07 | Phase 1 | UNKNOWN |
FDA Drug Approvals
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Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
---|---|---|---|---|---|
Preferred Pharmaceuticals Inc. | 68788-8123 | ORAL | 6 mg in 1 mL | 8/22/2023 | |
Macleods Pharmaceuticals Limited | 33342-258 | ORAL | 75 mg in 1 1 | 9/5/2022 | |
Zydus Lifesciences Limited | 70771-1711 | ORAL | 45 mg in 1 1 | 10/31/2022 | |
Zydus Lifesciences Limited | 70771-1710 | ORAL | 30 mg in 1 1 | 10/31/2022 | |
NuCare Pharmaceuticals,Inc. | 68071-2612 | ORAL | 75 mg in 1 1 | 1/5/2022 | |
Amneal Pharmaceuticals NY LLC | 60219-1265 | ORAL | 45 mg in 1 1 | 9/26/2022 | |
Amneal Pharmaceuticals NY LLC | 69238-1273 | ORAL | 6 mg in 1 mL | 12/30/2023 | |
Strides Pharma Science Limited | 64380-797 | ORAL | 30 mg in 1 1 | 12/8/2022 | |
NuCare Pharmaceuticals,Inc. | 68071-2528 | ORAL | 75 mg in 1 1 | 11/22/2021 | |
Cadila Healthcare Limited | 70771-1598 | ORAL | 6 mg in 1 mL | 8/5/2021 |
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 |
---|---|---|---|---|---|
SELTAVIR 30 CAPSULE 30MG | SIN16669P | CAPSULE | 30mg | 1/5/2023 |
NMPA Drug Approvals
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Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
---|---|---|---|---|---|
Oseltamivir Phosphate Capsules | 国药准字H20249291 | 化学药品 | 胶囊剂 | 11/5/2024 | |
Oseltamivir Phosphate Capsules | 国药准字H20253123 | 化学药品 | 胶囊剂 | 1/8/2025 | |
Oseltamivir Phosphate Capsules | 国药准字H20243972 | 化学药品 | 胶囊剂 | 6/11/2024 | |
Oseltamivir Phosphate Capsules | 国药准字H20249360 | 化学药品 | 胶囊剂 | 11/15/2024 | |
Oseltamivir Phosphate Capsules | 国药准字H20249330 | 化学药品 | 胶囊剂 | 11/15/2024 | |
Oseltamivir Phosphate Capsules | 国药准字H20244551 | 化学药品 | 胶囊剂 | 7/30/2024 | |
Oseltamivir Phosphate Capsules | 国药准字H20223173 | 化学药品 | 胶囊剂 | 3/29/2022 | |
Oseltamivir Phosphate Capsules | 国药准字H20243537 | 化学药品 | 胶囊剂 | 6/4/2024 | |
Oseltamivir Phosphate Capsules | 国药准字H20244552 | 化学药品 | 胶囊剂 | 7/30/2024 | |
Oseltamivir Phosphate Capsules | 国药准字H20243988 | 化学药品 | 胶囊剂 | 6/11/2024 |
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 |
---|---|---|---|---|---|
OSELTAMIVIR STRIDES oseltamivir (as phosphate) 75 mg capsule blister pack | 329884 | Medicine | A | 3/4/2022 | |
Oseltamivir Lupin Oseltamivir (as phosphate) 45 mg capsule blister pack | 328424 | Medicine | A | 12/3/2020 | |
OSELTAMIVIR STR oseltamivir (as phosphate) 45 mg capsule blister pack | 329879 | Medicine | A | 3/4/2022 | |
OSMIVIR oseltamivir (as phosphate) 30 mg capsule blister pack | 329880 | Medicine | A | 3/4/2022 | |
ALEMBIC OSELTAMIVIR oseltamivir (as phosphate) 45 mg hard capsule blister pack | 377317 | Medicine | A | 11/17/2022 | |
ALEMVIR oseltamivir (as phosphate) 45 mg hard capsule blister pack | 377324 | Medicine | A | 11/17/2022 | |
TAMIFLU oseltamivir (as phosphate) 75 mg capsule blister | 76017 | Medicine | A | 9/13/2000 | |
Oseltamivir GH Oseltamivir (as phosphate) 45 mg capsule blister pack | 328423 | Medicine | A | 12/3/2020 | |
TAMIFLU oseltamivir (as phosphate) 30 mg capsule blister pack | 145953 | Medicine | A | 8/8/2008 | |
TAMIFLU oseltamivir (as phosphate) 45 mg capsule blister | 145957 | Medicine | A | 8/8/2008 |