Regulatory Decision Summary for Auro-Cefixime
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?
This New Drug Submission (NDS) was filed to obtain market authorization for AURO-CEFIXIME (cefixime) Powder for Oral Suspension 100 mg/5 mL by Auro Pharma Incorporated. This submission was filed as an NDS since the Canadian Reference Product (CRP) for cefixime powder for oral suspension 5 mg/100 mL was not available on the Canadian market at the time of filing this NDS. A non-Canadian reference product (SUPRAX® of Astellas Pharma S.p.A. Italy, manufactured by Titolare A.I.C.) was used to conduct a bioequivalence study.
In the original NDS, the New Drug Quality Division (NDQD) had identified issues with the submission and recommended a Notice of Non-Compliance (NON), which was issued on November 09, 2016. The sponsor submitted a response to NON (R-NON) which was accepted into review on March 21, 2017. The sponsor has addressed all concerns raised by NDQD and the submission is recommended for clearance [Memo from New Drug Quality Division (NDQD) dated September 11, 2017.
Why was the decision issued?
Cefixime is a semisynthetic, cephalosporin antibiotic for oral administration. It exerts its bactericidal effect by attaching to penicillin binding proteins and inhibiting peptidoglycan synthesis, thus causing damage to the bacterial cell wall.
Based on the clinical safety and efficacy information presented in the original NDS, the overall benefit-harm-uncertainty profile of AURO-CEFIXIME (cefixime) Powder for Oral Suspension 100 mg/5 mL is considered to be positive.
However, a review of the original NDS submission by the NDQD (including chemistry and manufacturing information) was NOT considered to meet the requirements of Division C.08.002 of the Food and Drug Regulations. A Notice of Non-Compliance (NON) was recommended based on the major concerns by the NDQD. In its response to NON, the sponsor has addressed issues raised by NDQD. Following responses to requested further clarifications, the final NDQD recommendation for an NOC was issued on September 11, 2017.
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 |
|---|---|---|---|
| AURO-CEFIXIME | 02468689 | AURO PHARMA INC | CEFIXIME 100 MG / 5 ML |