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Withdrawal of FDA Approval of UKONIQ® (umbralisib)

The U.S. Food and Drug Administration (FDA) issued a notice in the Federal Register officially withdrawing approval of New Drug Application for UKONIQ® effective May 31, 2022.

  • For a copy of the FDA withdrawal notice click here  

The FDA withdrawal of approval follows the Company’s decision to voluntarily withdraw UKONIQ® from sale.

  • For the company’s press release with more information regarding the withdrawal of UKONIQ® click here  

For any questions related to the above information please contact: 1-877-848-9462.