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Home » FDA Goof Leads to Partial Withdrawal of Approval for Hemophilia Treatments
FDA Goof Leads to Partial Withdrawal of Approval for Hemophilia Treatments
The FDA sent letters to two companies Feb. 17, withdrawing part of the approvals it had granted them for their hemophilia products last year in response to their supplementary biologics license applications, due to the agency overlooking a pediatric exclusivity designation that is still in effect.