Oceana Therapeutics and Q-Med AB Achieve Key Milestone With the Submission of a Premarketing Application for FDA Approval of Solesta(R)
EDISON, N.J., & UPPSALA, Sweden--(BUSINESS WIRE)--Oceana Therapeutics and Q-Med AB today announced the filing of a Premarket Approval (PMA) application with the U.S. Food and Drug Administration (FDA) for Solesta® for the treatment of Fecal (or Bowel) Incontinence, a largely unsatisfied medical need afflicting millions of Americans.