The Food and Drug Administration (FDA) is withdrawing approval of two new drug applications (NDAs) held by Guerbet Group. Guerbet Group notified the Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.
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Guerbet Group; Withdrawal of Approval of Two New Drug Applications
The Food and Drug Administration (FDA) is withdrawing approval of two new drug applications (NDAs) held by Guerbet Group. Guerbet Group notified the Agency in writing that the d...
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82 FR 18916
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“Guerbet Group; Withdrawal of Approval of Two New Drug Applications,” thefederalregister.org (April 24, 2017), https://thefederalregister.org/documents/2017-08179/guerbet-group-withdrawal-of-approval-of-two-new-drug-applications.