Regulatory Decision Summary for GENTAMICIN INJECTION USP
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.
Product type:
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Type of submission:
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What was the purpose of this submission?
The purpose of this New Drug Submission (NDS) was to seek market authorization for Gentamicin Injection USP manufactured by Teligent OÜ (previously Alveda Pharmaceuticals Inc.).
Why was the decision issued?
Health Canada considers that the benefits of Gentamicin Injection USP outweigh the potential known risks associated with its use in the treatment of infections with laboratory tested susceptible bacteria.
The clinical efficacy and safety profile of Gentamicin Injection USP in this submission was supported by literature studies. The indications sought and the strains of bacteria identified as susceptible are identical to those approved for the other product currently marketed in Canada, Gentamicin Injection USP manufactured by Sandoz Canada Inc. The use of gentamicin is indicated in the treatment of serious infections (bacteremia, respiratory tract infections, urinary tract infections, infected wounds (surgical and traumatic) and bone and soft tissue infections) caused by laboratory confirmed susceptible strains of the following bacteria: Pseudomonas aeruginosa; Proteus species (indole negative and indole positive); Escherichia coli, Klebsiella pneumonia; Enterobacter aerogenes; Serratia marcescens; and Staphylococcus species (methicillin-susceptible strains only). The dosage recommendations are based on the target populations (including pediatric patients and patients with renal impairment), and the route of administration (intramuscular or intravenous injection).
The approved Product Monograph for Gentamicin Injection USP contains updated information with respect to Warnings and Precautions (Immune, neurologic, perioperative considerations, pediatrics and geriatrics), Adverse Reactions, Drug Interactions (serious drug interactions, drug-drug interactions and drug-vaccine interactions), and Dosage and Administration (pediatric dosing).
Based on the well-established safety profile of Gentamicin and the anticipated benefits associated with its use, the overall benefit-harm-uncertainty profile of Gentamicin for Injection is considered to be positive under the conditions of use described in the Product Monograph.
Decision issued
Approved; issued Notice of Compliance in accordance with the Food and Drug Regulations
Related Drug Products
| Product name | DIN | Company name | Active ingredient(s) & strength |
|---|---|---|---|
| GENTAMICIN INJECTION USP | 02457008 | HIKMA CANADA LIMITED | GENTAMICIN (GENTAMICIN SULFATE) 40 MG / ML |