Mylan's dipyridamole
Executive Summary
The generic firm reinstated its request with FDA for a hearing on the recent DESI notice to withdraw approval of dypridamole for the treatment of engina. By doing so, Mylan avoids having to withdraw its product from the market before final resolution of the dypridamole question. FDA had earlier published an April 10 Federal Register notice proposing to withdraw approval of the Mylan products after the company withdrew its hearing request.
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The generic firm reinstated its request with FDA for a hearing on
the recent DESI notice to withdraw approval of dypridamole
for the treatment of engina. By doing so, Mylan avoids having to
withdraw its product from the market before final resolution of the
dypridamole question. FDA had earlier published an April 10
Federal Register notice proposing to withdraw approval of
the Mylan products after the company withdrew its hearing request.
|