Tetra Bio-Pharma Inc.
a leader in cannabinoid-derived drug discovery and development is providing its shareholders with another regulatory update on the REDUVOTM New Drug Submission (NDS). The last update was provided on
November 18, 2022.
December 21, 2022, the Company received a second Clarification Request (Clarifax) from Health Canada regarding the product's Risk Management Plan, which is not atypical for a controlled substance drug. The Company will be submitting the response to Health Canada within the allowed timeframe. The Company cannot comment on Health Canada's response timelines. Questions/feedback from Health Canada are received as the review of the dossier progresses through different review streams.
REDUVOTM is a soft gel capsule used to treat chemotherapy-induced nausea and vomiting (CINV). It is also used to treat weight loss and severe nausea in people living with HIV infection. The active pharmaceutical ingredient in REDUVOTM is dronabinol, also known as THC, a synthetic form of the active natural substance in cannabis. REDUVOTM 5-year cumulative gross sales expected to reach
About Tetra Bio-Pharma
is a leader in cannabinoid-derived drug discovery and development with a FDA and a Health Canada cleared clinical program aimed at bringing novel prescription drugs and treatments to patients and their healthcare providers. Their evidence-based scientific approach has enabled them to develop a pipeline of cannabinoid-based drug products for a range of medical conditions, including pain, inflammation, and oncology. With patients at the core of what they do, Tetra Bio-Pharma is focused on providing rigorous scientific validation and safety data required for inclusion into the existing biopharma industry by regulators, physicians and insurance companies.
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