- Voyageur Pharmaceuticals Ltd. (VM) has completed the production test batch of its SmoothX product
- The SmoothX oral formula is used in the CT scanning of a person’s abdomen and pelvis
- The company will now produce commercial volumes of SmoothX to supply the market
- After stability tests, SmoothX will then undergo approval for sale in the U.S. market
- CEO Brent Willis sat down with Daniella Atkinson to discuss the news
- Voyageur Pharmaceuticals Ltd. (VM) is unchanged trading at $0.07 per share as of 3:23 p.m. EST
Voyageur Pharmaceuticals (VM) has completed the production test batch of its SmoothX product for the computerized tomography (CT) imaging market in Canada.
The SmoothX oral formula has been designed for use in CT scanning of a person’s abdomen and pelvis to outline the gastrointestinal tract for adults and children.
Voyageur stated it has produced the recent batch that adheres to the U.S. Food and Drug Administration (FDA) and Health Canada-compliant quality management system. This system ensures a consistent and high-quality product is delivered.
The company’s focus will now shift to scaling commercial volumes of SmoothX to supply the market.
After 180 days of stability tests, the SmoothX will be submitted to the FDA for approval of the product to be sold in the U.S. market. Voyageur expects to make the submission during the second quarter of 2023.
CEO Brent Willis sat down with Daniella Atkinson to discuss the news.
“We have been engaged with the FDA on the path to approval for SmoothX since earlier this year and are now formally in contact with the FDA’s Office of Generic Drugs regarding the specific requirements of approval for SmoothX.”
Voyageur continues to develop and test four additional Health Canada-approved imaging products for the Canadian radiology market. It currently holds Canadian approval licenses for five radiology contrast media products.
Voyageur Pharmaceuticals Ltd. (VM) is unchanged trading at $0.07 per share as of 3:23 p.m. EST.