ANDA Sponsors Silent As Novartis Confirms US Gilenya Generic Entries
Ten Generics Manufacturers Hold FDA-Approved Fingolimod ANDAs
One of the largest small molecule opportunities in the US, Novartis’s Gilenya to treat relapsing-remitting multiple sclerosis, now has generic competition, the originator has confirmed following a series of favorable court rulings for ANDA sponsors.