Regulatory Decision Summary for Amoxicillin Sodium And Potassium Clavulanate For Injection
Review decision
The Regulatory Decision Summary explains Health Canada’s decision for the product seeking market authorization. The Regulatory Decision Summary includes the purpose of the submission and the reason for the decision.
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What was the purpose of this submission?
The purpose of this New Drug Submission (NDS) is to seek market authorization for Amoxicillin Sodium And Potassium Clavulanate For Injection for the treatment of the following infections in adults and children:
Severe infections of the ear, nose and throat (such as mastoiditis, peritonsillar infections, epiglottitis, and sinusitis when accompanied by severe systemic signs and symptoms)
Acute exacerbations of chronic bronchitis (adequately diagnosed)
Community acquired pneumonia
Cystitis
Pyelonephritis
Skin and soft tissue infections in particular cellulitis, animal bites, severe dental abscess with spreading cellulitis
Bone and joint infections, in particular osteomyelitis
Intra-abdominal infections
Female genital infections.
Prophylaxis against infections associated with major surgical procedures in adults, such as those involving the:
Gastrointestinal tract
Pelvic cavity
Head and neck
Biliary tract surgery.
Sandoz filed this submission as a Submission Relying on Third Party Data (SRTD) to support safety and efficacy of the proposed drug product. The original clinical studies which supported the authorization of the innovator product, Augmentin (GSK, GlaxoSmithKline), in Europe are outdated; therefore, this submission relied substantially on literature and market experience. In Canada, the oral formulation of amoxicillin and clavulanic acid has been marketed as tablets and oral suspension (CLAVULIN) by GSK since 1992. Amoxicillin and clavulanic acid are on the Canadian Prescription Drug List (PDL).
Why was the decision issued?
There is an ongoing and urgent concern regarding antimicrobial resistance in Canada and worldwide. Beta-lactam antibiotics such as amoxicillin are at risk of becoming ineffective against common Gram-positive and Gram-negative microorganisms due to the emergence of resistance. The combination of amoxicillin and clavulanic acid is approved in Canada in the oral dosage form, however, not as an intravenous (i.v.) formulation. The addition of the i.v. formulation is a valuable addition to the prescribing physicians antibiotic toolkit.
Based on the totality of quality, safety, and efficacy data assessed in this NDS, Health Canada considers the benefit-harm-uncertainty profile of Amoxicillin Sodium and Potassium Clavulanate for Injection to be favorable for the treatment of various serious bacterial infections in adults and children when caused by susceptible bacteria.
Decision issued
Approved; issued a Notice of Compliance in accordance with the Food and Drug Regulations.
Related Drug Products
| Product name | DIN | Company name | Active ingredient(s) & strength |
|---|---|---|---|
| AMOXICILLIN SODIUM AND POTASSIUM CLAVULANATE FOR INJECTION | 02495937 | SANDOZ CANADA INCORPORATED | AMOXICILLIN (AMOXICILLIN SODIUM) 2000 MG / VIAL CLAVULANIC ACID (CLAVULANATE POTASSIUM) 200 MG / VIAL |
| AMOXICILLIN SODIUM AND POTASSIUM CLAVULANATE FOR INJECTION | 02495929 | SANDOZ CANADA INCORPORATED | AMOXICILLIN (AMOXICILLIN SODIUM) 1000 MG / VIAL CLAVULANIC ACID (CLAVULANATE POTASSIUM) 200 MG / VIAL |
| AMOXICILLIN SODIUM AND POTASSIUM CLAVULANATE FOR INJECTION | 02495910 | SANDOZ CANADA INCORPORATED | AMOXICILLIN (AMOXICILLIN SODIUM) 500 MG / VIAL CLAVULANIC ACID (CLAVULANATE POTASSIUM) 100 MG / VIAL |