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Home » FDA to Revoke ANDAs for Generic MiraLAX Almost Six Years After Asking for Hearing Requests
FDA to Revoke ANDAs for Generic MiraLAX Almost Six Years After Asking for Hearing Requests
The FDA is moving to withdraw ANDAs for four generic versions of the laxative MiraLAX, nearly six years after the agency issued a notice of opportunity for a hearing (NOOH) threatening to take away the marketing clearance because the reference product had turned OTC while the generics remained prescription-based.