Solesta regulatory update

FDA approved a PMA from Oceana for Solesta to treat fecal incontinence. Oceana previously said it will conduct a post-approval study to evaluate long-term treatment of Solesta. In December, an FDA advisory committee voted 5-0, with 1 abstention, that the benefit-risk profile of Solesta supported approval (see BioCentury, Dec. 6, 2010, & April 11, 2011). ...