Summary of Cancellation for Dronabinol (*Reduvo)
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:
Medicinal ingredient(s):
Dronabinol
Therapeutic area:
Antiemetics and Antinauseants
Type of submission:
New Drug Submission
Control number:
240372
Decision issued:
No decision was issued by Health Canada. The company chose to cancel the submission before a final decision was issued.
Date of Cancellation:
2023-05-01
What was the purpose of this submission?
This New Drug Submission (NDS) was filed to obtain approval for Reduvo (dronabinol) for use in Chemotherapy Induced Nausea and Vomiting (CINV) and Anorexia associated with weight loss in patients with Acquired Immunodeficiency Syndrome (AIDS).
The submission was filed through the Submissions Relying on Third-Party Data (SRTD) pathway due to the absence of clinical studies.
What did the company submit to support its submission?
The active ingredient of Reduvo, dronabinol, was marketed in Canada under a different brand name (Marinol) from 1988 until 2012, when the Drug Identification Number (DIN) was subsequently cancelled (not for safety or efficacy reasons). The Reduvo submission relied, in part, on the previously marketed Marinol product which was approved for the same indications.
The initial submission contained literature references with a systematic review for each requested indication, and a bioequivalence study from 2005. Several deficiencies were noted in the initial submission, precluding completion of the review and leading to the issuance of a Notice of Deficiency (NOD).
In the response to NOD that was filed on May 30, 2022, the sponsor supplied clinical overviews, summaries of efficacy and safety, summaries of pre-clinical data with references, and two genotoxicity studies. During the course of Health Canada’s review of the response to NOD, the sponsor cancelled their submission.
What was the status of the submission when it was cancelled? What was Health Canada’s assessment of the submission at the time of cancellation?
At the time of the cancellation, on May 1, 2023, Health Canada had identified deficiencies in bioequivalence, manufacturing, and quality aspects of the submission. The sponsor chose to cancel their submission before a decision was issued.
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.
*Proposed Brand Name:
Reduvo
Manufacturer:
Tetra Bio-Pharma Inc.
Drug Identification Numbers issued:
N/A
Date filed:
2021-01-13