Innovata's Adept gets FDA approvable letter

Nottingham, UK-based Innovata says that the US Food and Drug Administration has issued an approvable letter relating to the firm's Adept (4% icodextrin) adhesion reduction solution. The document indicated that the product has potential, as an adjunct to good surgical technique for reducing the occurrence of post-surgical adhesion in patients receiving surgery as a treatment for gynecological laparoscopic adhesiolysis.

The company added that the FDA's letter follows the unanimous recommendation in March of this year by the Obstetrics and Gynecology Devices panel of the FDA that the product be granted marketing approval. The letter details that the FDA will continue its review of the drug, specifically the product labeling, for which the agency has requested amended copy from the firm covering adverse event data and warnings. The FDA also requires that Innovata submits plans for post-approval safety monitoring, which the company says it will file in the near future.

Adept, which the firm licenses to USA-based Baxter International for marketing as part of its BioSurgery business, has been available in Europe since 2000, and has been used in the treatment of over 100,000 surgical patients to date.