Regulatory Decision Summary for Obraro
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:
Summary of Cancellation: naloxone hydrochloride dihydrate (*OBRARO)
Medicinal ingredient(s):
Therapeutic area:
Type of submission:
Control number:
Overview
Decision issued
No decision was issued by Health Canada. The company cancelled its submission before a final decision was issued.
Date of cancellation
June 17, 2019
What was the purpose of this submission?
This New Drug Submission (NDS) was filed to obtain market authorization for non-prescription Obraro (naloxone hydrochloride) nasal spray for emergency use in an opioid overdose.
What did the company submit to support its submission?
Purdue Pharma submitted clinical and labelling components.
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 nearing completion. Health Canada had identified some deficiencies in the data that would have precluded issuing an approval. The sponsor chose to cancel their submission.
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:
Obraro