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Tetra Bio-Pharma Provides Update on Its REDUVO™ New Drug Submission

Tetra Bio-Pharma Provides Update on Its REDUVO™ New Drug Submission.

articleTetra Bio-pharma Inc.November 18, 20225/news/tetra-bio-pharma-provides-update-on-its-reduvotm-new-drug-submission
Tetra Bio-Pharma Provides Update on Its REDUVO™ New Drug Submission

About this update from Tetra Bio-pharma Inc.

Tetra Bio-Pharma Provides Update on Its REDUVO™ New Drug Submission /* 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; } Tetra Bio-Pharma Provides Update on Its REDUVO™ New Drug Submission PR Newswire MONTREAL, Nov. 18, 2022 MONTREAL, Nov. 18, 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 a regulatory status update on the REDUVO™ New Drug Submission (NDS).  On December 30, 2020, the Company submitted its first new drug submission ("NDS") for the REDUVO™ soft gel capsules to Health Canada to obtain approval and a drug identification number ("DIN") for the prescription drug.  The last response to Health Canada was end of May 2022.  On November 16, the Company received a Clarification Request (Clarifax) from Health Canada regarding the product labels.  The Company will be submitting the response to Health Canada within the allowed timeframe. 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-PharmaTetra 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 require...

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