Regulatory Decision Summary for Iron Dextran Injection USP

 

Decision issued

A Notice of Deficiency was issued by Health Canada. The company cancelled its submission before a final decision was issued.

Date of cancellation

June 8, 2017

What was the purpose of this submission?

This New Drug Submission (NDS) was filed to obtain market authorization for Iron Dextran Injection USP. Iron Dextran Injection USP is a parenteral iron supplement proposed for use as treatment of iron deficiency in adults when oral iron preparations cannot be used, e.g., due to intolerance, or in case of demonstrated lack of effect of oral iron therapy or when there is a clinical need to deliver iron rapidly to iron stores.

What did the company submit to supports its submission?

This NDS was filed based on third-party data (literature and market experience). The sponsors rationale for the third-party data submission was that the product was approved by the European Union (EU) Health Authorities, the product had extensive marketing experience of the proposed product in EU (over the last 10 years) demonstrating high benefit/risk ratio, as well as the recommendation published by European Medicine Agency (EMA) on June 27, 2013 underlining the benefit of lower molecular weight iron products in regards to adverse events. Further to the rationale, the sponsor submitted chemistry and manufacturing data, bioavailability data, evidence of current market experience in another jurisdiction, and a systematic review.

What was the status of the submission when it was cancelled? What was Health Canadas assessment of the submission at the time of cancellation?

At the time of the cancellation, the review of the submission was not complete; however Health Canada had identified major deficiencies in the information provided that precluded continuation of the review. Health Canada did not consider safety and efficacy data provided to be sufficient to support market authorization. This consideration was made given that:

1. a linkage between the proposed product and the products studied or described in the provided literature references had not been established; and
2. deficiencies in these references were identified.

As such, Health Canada considered there to be insufficient information to support development of a product monograph providing for the safe and effective use of Iron Dextran Injection USP. As a result, Health Canada issued a Notice of Deficiency (NOD) seeking additional information.

Following issuance of the NOD, Sandoz Canada Inc. withdrew the submission for Iron Dextran Injection USP as a parenteral iron supplement proposed for use as treatment of iron deficiency in adults when oral iron preparations cannot be used. This withdrawal was without prejudice to a resubmission containing information addressing the identified deficiencies.

 

What consequences does the cancellation have for patients accessing the drug under the Special Access Programme (SAP), or via clinical trials?

There is no expected impact for patients using SAP or in clinical trials.

Additional information

*Proposed Brand Name:
Iron Dextran Injection USP