EspanaSalude.Org

Vegans at increased risk of developing blood clots and atherosclerosis

December 22, 2015

With this letter, FDA has determined that the Solesta Premarket Approval Application (PMA) is approvable subject to certain requirements relative to labeling and manufacturing. Oceana said it welcomes the opportunity to work with the FDA to satisfy, as quickly as possible, the agency's requests for final marketing approval. Also, consistent with Oceana's expectations and plans, the Company will carry out a post-approval study to evaluate long-term treatment data.

"The Solesta PMA was submitted less than a year ago and we are pleased that its progress through the regulatory process is well within our timeline for an anticipated approval and launch this year," said Tierney. "We are excited about Solesta's prospects as a unique treatment for bowel incontinence and are well prepared to provide physicians and patients with product support by leveraging the strengths of our U.S. operating infrastructure and building out a dedicated Solesta sales force."

SOURCE Oceana Therapeutics