FDA Advisory Committee Recommends Approval of Oceana's Solesta
Following their review of the Premarketing Approval Application (PMA) data, the Panel voted to recommend approval. Although the FDA is not required to follow Panel recommendations, it often does.
Oceana Therapeutics obtained the exclusive worldwide marketing rights to Solesta from Q-Med in June 2009 and has since collaborated on controlled studies of the product’s effectiveness and safety. Solesta utilizes Q-med’s proprietary NASHA technology.
According to the company, Solesta is an injectable gel that has been developed to be administered in an outpatient setting without the need for anesthesia.
John Spitznagel, chairman and CEO of Oceana, said: “The Advisory Committee’s recommendation represents a significant milestone toward obtaining US approval of Solesta for a largely unsatisfied medical problem.
“Bowel incontinence can substantially impair a patient’s quality of life, and currently many patients fall into a treatment gap that exists between conservative therapies such as diet control and more aggressive intervention such as surgery. Thus, we believe Solesta has the potential of becoming an important treatment option for US patients with bowel incontinence.”
David Tierney, president and COO of Oceana, said: “We are pleased with the Panel's recommendation for approval of Solesta and look forward to continuing discussions with the FDA during the remainder of this regulatory review process.
“Today’s announced key progress toward US approval is a testimony to the dedication, experience and excellence of the Oceana team and the strength of our working relationship with Q-Med.”
Will the approval benefit the firm?
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