Tetra Bio-Pharma Inc (TSE:TBP) (OTCQB:TBPMF) (FRA:JAM1) announced that the company’s Dronabinol Soft Gel capsules have completed the screening phase of the New Drug Submission (NDS) file submitted to Health Canada on December 30.
Tetra Bio-Pharma said a successful application for the drug, which would be named REDUVO, will provide the company with Canada’s only Drug Identification Number (DIN) for a THC-based prescription drug.
“We are pleased to have successfully cleared this critical step in the NDS application. The application will now enter the next phase of review, thereby allowing Tetra to maintain its anticipated launching of REDUVO in the second half of 2021,” Tetra Bio-Pharma CEO Dr. Guy Chamberland said in a statement.
READ: Tetra Bio-Pharma gearing up for a milestone 2021 as it advances coronavirus drug candidate ARDS-003 to human trials
Dr. Chamberland added: “This drug launch for Tetra is a major milestone as it moves the company from a pre-revenue biotech to in revenue for 2021, which is great news for Tetra employees and shareholders.”
“We anticipate strong demand for the only THC-based drug in Canada, that will be prescribed by physicians.”
Tetra Bio-Pharma said REDUVO will allow the company to establish a revenue stream based on a synthetic cannabinoid drug for major markets in Chemotherapy-induced Nausea and Vomiting (CINV).
It added that it estimates the addressable Canadian market for REDUVO to be C$80 million by 2022.
The company noted that Health Canada has recommended an unconventional regulatory pathway and therefore requested additional information to fulfill all requirements of that proposed prescription drug approval pathway.
Tetra is working towards submitting the response to Health Canada within the allowable timeframe.
Tetra Bio-Pharma is a pioneer in immunomodulator drug discovery and development with a US Food & Drug Administration (FDA) and a Health Canada-approved clinical program aimed at bringing novel prescription drugs and treatments to patients and their healthcare providers.
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