Abbreviated New Drug Application (ANDA) disputes regarding Injectafer® (ferric carboxymaltose) have now been settled
ST. GALLEN, Switzerland & SHIRLEY, N.Y.-Monday 20 December 2021 [ AETOS Wire ]
(BUSINESS WIRE)-- Regulatory News:
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AD HOC ANNOUNCEMENT PURSUANT TO ART. 53 LR
Vifor Pharma Group and its partner American Regent, Inc., a Daiichi Sankyo Group company, today announced that they have reached settlement agreements with Mylan Laboratories Ltd., and Sandoz, Inc., that resolve the patent litigation brought in response to Abbreviated New Drug Applications seeking approval by the U.S. Food and Drug Administration to market a generic version of Injectafer®.
Under the terms of the settlements, Vifor Pharma and American Regent will grant Mylan Laboratories Ltd., and Sandoz, Inc.,
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