FDA May Modify Orphan Exclusivity Reg, But Label Carve-Out Policy Is Intact
A district court rejects FDA’s “clinical superiority” requirement for Gralise orphan exclusivity, while another court upholds the agency’s finding that an ANDA label carve-out may overlap partially with a protected method of use.
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Court orders US FDA to award Bendeka seven years of exclusivity without requiring clinical superiority test; law codifying FDA policy passed prior to suit and is not retroactive.
Depomed argues in a suit against FDA that it should not have to show Gralise (gabapentin) is clinically superior to Neurontin since Neurontin never received an orphan drug designation or orphan exclusivity.
Our infographic illustrates the recommendations in FDA’s COVID-19 pandemic recovery and preparedness plan, ranging from strengthening the EUA process to managing the backlog of pending inspections.