- The D.C. Circuit Court of Appeals has concluded the radiographic contrast agent barium sulfate qualifies as a device rather than a drug
- This favourable ruling will result in an accelerated product rollout and significant cost savings for Voyageur
- Voyageur has begun work preparing for product applications in markets globally
- Voyageur Pharmaceuticals Ltd is engaged in the development of pharmaceutical ingredients (API) minerals
- Voyageur Pharmaceuticals (VM) is unchanged, trading at C$0.175 per share at 1:30 pm ET
The D.C. Circuit Court of Appeals has concluded that the radiographic contrast agent barium sulfate qualifies as a device rather than a drug.
This ruling has a significant impact on Voyageur’s planned product rollout in the United States with management estimating significant cost savings and reduced timelines to bring Voyageur’s products to the US markets.
As a result of this ruling, the timelines to finalize and gain approval of each device are expected to be significantly shorter than a drug registration, with the filing fees estimated to be reduced from US$196,868 to US$12,432 per product certification.
Until the FDA formulates the rules and regulations for filing and approvals of barium as a device, Voyageur will be working closely with the FDA Center for Devices and Radiological Health (CDRH) to secure approval of Voyageur’s barium contrast media product line under a medical device pathway.
Voyageur has engaged a world-class group of consultants to further accelerate the product rollout of its barium radiographic contrast products. Voyageur has begun work preparing for product applications in markets globally, including the US, United Kingdom, South America and Southeast Asia.
Voyageur Pharmaceuticals Ltd is engaged in the development of pharmaceutical ingredients (API) minerals. The company focuses on developing barium and iodine radiocontrast products and bromine-based pharmaceutical products. It provides its products to medical applications and diagnostics.
Voyageur Pharmaceuticals (VM) is unchanged, trading at C$0.175 per share at 1:30 pm ET.
