Based on the FDA feedback, the company will be moving into Phase II/III on one NDA Program, and into Phase II on the other.
In line with the company’s strategic corporate mission, both NDAs have projected approvals of late 2016 and early 2017.
Avion Pharmaceuticals CEO Mark Pugh said the company is happy about the feedback from the FDA and the unique therapeutic benefits that these new products will be able to provide to its patients.
"Avion continues to diligently pursue product opportunities that are targeted to improve the health and well-being of women and babies," Pugh said.
"The positive news on the progress of these two NDAs will allow us to continue to work toward achieving our business goals."
Avion VP and head of Research and Development Allen Fields said, "Avion’s strategy of continuing to work with the best consultants, clinical research organizations, and manufacturers, clearly provides Research and Development the ability to support corporate goals and provide our customers with unique products."