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Affymax and Takeda Announce a Nationwide Voluntary Recall of All Lots of OMONTYS® (peginesatide) Injection

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Affymax (NASDAQ: AFFY) and Takeda Pharmaceutical Company (OTC: TKPYY) decided on Saturday to voluntarily recall all lots of OMONTYS
(peginesatide) Injection to the user level as a result of new
postmarketing reports regarding serious hypersensitivity reactions,
including anaphylaxis, which can be life-threatening or fatal. The
companies have been working actively with the U.S. Food and Drug
Administration (FDA) which has indicated its agreement with this
decision. The companies have also issued a letter to health care
professionals indicating that no new or existing patients should receive
OMONTYS.

To date, fatal reactions have been reported in approximately 0.02% of
patients following the first dose of intravenous administration. The

See full press release

Posted-In: News Guidance Contracts Management Global

 

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