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REDUVO™ Marketing Approval on the Right Path

REDUVO™ Marketing Approval on the Right Path.

articleTetra Bio-pharma Inc.December 22, 20224/news/reduvotm-marketing-approval-on-the-right-path
REDUVO™ Marketing Approval on the Right Path

About this update from Tetra Bio-pharma Inc.

REDUVO™ Marketing Approval on the Right Path /* Style Definitions */ span.prnews_span { font-size:8pt; font-family:"Arial"; color:black; } a.prnews_a { color:blue; } li.prnews_li { font-size:8pt; font-family:"Arial"; color:black; } p.prnews_p { font-size:0.62em; font-family:"Arial"; color:black; margin:0in; } REDUVO™ Marketing Approval on the Right Path PR Newswire MONTREAL, Dec. 22, 2022 Second Clarifax received from Health Canada.MONTREAL, Dec. 22, 2022 /PRNewswire/ - Tetra Bio-Pharma Inc. ("Tetra" or the "Company") (TSX: TBP) (OTCQB: TBPMF) (FRA: JAM1) a leader in cannabinoid-derived drug discovery and development is providing its shareholders with another regulatory update on the REDUVO™ New Drug Submission (NDS). The last update was provided on November 18, 2022. On 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. About REDUVO™         REDUVO™ 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 REDUVO™ is dronabinol, also known as THC, a synthetic form of the active natural substance in cannabis. REDUVO™ 5-year cumulative gross sales expected to reach $121M. About Tetra Bio-Pharma Tetra Bio-Pharma (TSX: TBP) (OTCQB: TBPMF) (FRA:JAM1) 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 ...

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