Overview
A semi-synthetic antibiotic related to penicillin, Naficillin is a narrow-spectrum beta-lactam antibiotic drug. It is a beta-lactamase-resistant penicillin that is indicated for the treatment of Staphylococcal infections caused by strains that are resistant to other penicillins, except those caused by MRSA. It may be used as a first-line therapy in Methicillin-Sensitive Staphylococcus aureus infections .
Background
A semi-synthetic antibiotic related to penicillin, Naficillin is a narrow-spectrum beta-lactam antibiotic drug. It is a beta-lactamase-resistant penicillin that is indicated for the treatment of Staphylococcal infections caused by strains that are resistant to other penicillins, except those caused by MRSA. It may be used as a first-line therapy in Methicillin-Sensitive Staphylococcus aureus infections .
Indication
Indicated in the treatment of infections caused by penicillinase-producing staphylococci which have demonstrated susceptibility to the drug.
Associated Conditions
- Bacterial Infections
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2021/03/01 | Phase 2 | Completed | |||
2013/08/14 | Phase 3 | Completed | Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) | ||
2007/01/30 | Phase 2 | Completed | Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Fresenius Kabi USA, LLC | 63323-328 | INTRAMUSCULAR, INTRAVENOUS | 2 g in 8 mL | 5/17/2019 | |
| Eugia US LLC | 55150-122 | INTRAMUSCULAR, INTRAVENOUS | 1 g in 4 mL | 1/31/2024 | |
| NorthStar Rx, LLC | 72603-211 | INTRAMUSCULAR, INTRAVENOUS | 1 g in 4 mL | 3/27/2024 | |
| Fresenius Kabi USA, LLC | 63323-327 | INTRAVENOUS, INTRAMUSCULAR | 1 g in 4 mL | 5/17/2019 | |
| Steriscience Specialties Private Limited | 82449-504 | INTRAMUSCULAR, INTRAVENOUS | 2 g in 1 1 | 10/17/2023 | |
| Claris Lifesciences, Inc. | 36000-175 | INTRAMUSCULAR, INTRAVENOUS | 1 g in 1 1 | 10/18/2011 | |
| WG Critical Care, LLC | 44567-221 | INTRAMUSCULAR, INTRAVENOUS | 1 g in 1 1 | 9/15/2021 | |
| Methapharm Inc. | 67850-032 | INTRAMUSCULAR, INTRAVENOUS | 2 g in 2 g | 3/14/2019 | |
| Armas Pharmaceuticals Inc. | 72485-406 | INTRAMUSCULAR, INTRAVENOUS | 2 g in 1 1 | 11/1/2023 | |
| Steriscience Specialties Private Limited | 82449-503 | INTRAMUSCULAR, INTRAVENOUS | 1 g in 1 1 | 10/17/2023 |
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 |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Nafcillin Sodium for Injection | 国药准字H20153082 | 化学药品 | 注射剂 | 2/21/2020 |
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 |
|---|---|---|---|---|---|
| No TGA approvals found for this drug. | |||||