Lifecore Wins FDA Nod for Adhesion Prevention Product Article 9B

From: KathFindlay (klfindlay@adhesions.org.uk)
Thu Nov 22 19:47:09 2001


Lifecore Wins FDA Nod for Adhesion Prevention Product Article 9B ---------------------------------------------------------------------------- ---- ----------------------------------------------------------------------------

---------------------------------------------------------------------------- WASHINGTON (Reuters Health) Nov 20 - Lifecore Biomedical Inc. has received final clearance from the US Food and Drug Administration (FDA) to market its Gynecare Intergel adhesion prevention solution, the Chaska, Minnesota-based medical device maker reported on Monday.

Lifecore said it expects the product to be rolled out in the first quarter of 2002. It is indicated for the reduction of the occurrence and severity of post-reproductive-surgery adhesions. Intergel will be sold by Johnson & Johnson's Ethicon Inc., which already markets the product in some regions outside the US.

The FDA's decision to allow the sale of Intergel is a reversal of its original position. In November 2000, the agency said it would not clear the product, citing concerns about a possible increase in the risk of post-surgical infections as well as doubts about whether the gel offered a meaningful benefit.

However, the agency's Medical Devices Dispute Resolution Panel later urged the FDA to reconsider its decision. It was the first such meeting of the dispute panel, which was created in 1997 to give companies a means to protest the agency's decisions.

At the meeting, Lifecore argued that the FDA failed to consider more robust European data and a modified analysis of US data showing that the gel reduced the incidence of adhesions by about 45%.

In October, the company said it had received notice that the product would be cleared for sale once the label was finalized.

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  In Friendship Kath Findlay
    The UK Adhesion Society
kath.findlay@adhesions.org.uk
  http://www.adhesions.org.uk
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