ReGen Biologics has sued the FDA over the agency's decision to rescind its previous approval of the company's Menaflex knee repair device, according to a report by the Wall Street Journal.
The WSJ said the original 2008 approval came amid lobbying pressure on the agency. In its reversal in March 2011, the FDA said it determined in a new review that Menaflex — a collagen-based surgical mesh used to reinforce damaged or weakened soft tissue in knees — didn't meet criteria for the approval pathway that was used.
ReGen filed for Chapter 11 bankruptcy protection in April, days after the FDA pulled its approval of Menaflex. The company said its product is safe and effective and challenged the legitimacy of the FDA review used to re-examine its 2008 decision.
Read the Wall Street Journal report on Menaflex.
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