Containment Drug Delivery Systems Drugs FDA Approval 
Drug Discovery World
AUGUST 9, 2023
The new acquisition gives Biogen rights to Reata’s portfolio of products for neurological diseases, including the FDA-approved Skyclarys (omaveloxolone), the only approved treatment for Friedreich’s ataxia (FA) in the United States.
FDA Law Blog
JUNE 13, 2024
Though some drug companies have been reluctant to delist certain patents from the Orange Book, the District Court of New Jersey just ordered Teva to delist 5 of its patents that it deemed improperly listed. The Court addressed Teva’s valid argument that the Inhaler Patents are drug product patents and thus listable.
FDA Law Blog
MARCH 12, 2024
Koblitz — After years of silence from FDA on whether certain patents could be listed in the Orange Book, some manufacturers of drug and device combination products have had a rude awakening lately.
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