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Mylan Presses On With US Tecfidera Launch ‘At Risk’

Follows First FDA Approval For Rival To MS Blockbuster

 
• By Dean Rudge

Facing an appeal on a favorable US district court decision, Mylan has opted to launch the first generic Tecfidera in the US “at risk,” after obtaining FDA approval and seeing Biogen’s bid for injunctive relief shot down earlier this month.

Risk
Mylan has launched the first generic Tecfidera product in the US despite ongoing litigation • Source: Shutterstock

Mylan has decided to introduce “at risk” the first generic version of Biogen, Inc.’s $3.3bn Tecfidera (dimethyl fumarate) in the US following Food and Drug Administration approval for its abbreviated new drug application, with litigation still pending over the last remaining Tecfidera patent listed in the agency’s Orange Book.

Market entry was confirmed by Mylan on 19 August, hours after the FDA’s database of approved drugs showed the company as holding approval for the first and only AB-rated ANDA...

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