With the issuance of its mandate on January 28, 2022, in Catalyst Pharmaceuticals, Inc. v. Becerra, the U.S. Court of Appeals for the Eleventh Circuit has upheld the orphan exclusivity for Catalyst Pharmaceuticals, Inc....more
Wednesday, FDA released a letter stating how the agency intends to implement the scope of orphan drug exclusivity awarded to Eagle Pharmaceuticals’ Bendeka (bendamustine HCl) by the D.C. Circuit Court in Eagle...more
2/22/2019
/ Abbreviated New Drug Application (ANDA) ,
FDA Approval ,
FDA Reauthorization Act ,
FDARA ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Healthcare ,
Life Sciences ,
Orphan Drugs ,
Pharmaceutical Industry ,
Prescription Drugs ,
Product Exclusivity ,
Regulatory Agenda ,
Regulatory Oversight ,
Reversal
FDA Commissioner Scott Gottlieb, M.D. recently announced four steps FDA will be taking to ensure that the Orange Book (FDA’s publication of Approved Drug Products with Therapeutic Equivalence Evaluations) provides the...more
2/4/2019
/ Abbreviated New Drug Application (ANDA) ,
Comment Period ,
FDA Approval ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Orange Book ,
Patent Applications ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Product Packaging ,
Regulatory Agenda