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Tetra Bio-Pharma Inc., a leader in cannabinoid-derived drug discovery and development today announced that it received a letter from the United States Food and Drug Administration (FDA), granting a Type C meeting to discuss safety and labelling requirements for obtaining marketing approval under the 505(b)(1) regulatory pathway for its QIXLEEF™.
QIXLEEF™ is a botanical inhaled investigational new drug with a fixed ratio of THC and CBD that meets USA cGMP regulatory requirements. The delivered-dose uniformity (DDU) of the aerosol generated by the Mighty Medic® medical device meets the criteria established by FDA for inhalation aerosols (also known as metered dose inhalers (or MDIs)) and inhalation powders (also known as dry powder inhalers (or DPIs)). The DDU is a measure of the drug discharged from the mouthpiece of an inhalation device and compares that measurement to the target delivered dose. Meeting the DDU specification is critical for a quality inhaled drug product.
Earlier this year, Tetra announced it received from the Malta Medicines Authority (MAA) a Scientific Advice Assessment (SAA) Report. The Report provided positive feedback on Tetra’s drug development plan for QIXLEEF™ and eligibility for submitting a Marketing Authorization Application (MAA) under Directive 2001/83/EC (Directive). The SAA Report endorsed Tetra’s proposed plan to address the nonclinical safety requirements for submitting a marketing approval application for QIXLEEF™.
These safety studies are both time consuming and very costly and can impact the timing of the submission of a marketing application. Dr. Guy Chamberland, Chief Executive Officer (CEO) and Chief Regulatory Officer (CRO) of Tetra Bio-Pharma said “the MAA’s response confirmed that our nonclinical safety strategy is acceptable and would satisfy the requirements of article 8 of the Directive. Now we need to obtain the FDA’s final guidance on this strategy to ensure QIXLEEF™ makes it to the market at the lowest cost.”
About Tetra Bio-Pharma
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.
For more information visit: www.tetrabiopharma.com
