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Mylan Pulls Generic Gilenya Application Over Study Concerns

As Accord Withdrawal Of Erlotinib Also Revealed By EMA's CHMP

 
• By Dean Rudge

Separate concerns raised by the EMA over bioequivalence studies have led Mylan and Accord to withdraw generic applications, including the former’s generic version of Gilenya for the treatment of multiple sclerosis.

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Mylan and Accord will have to resubmit their applications • Source: Shutterstock

Mylan has withdrawn its marketing authorization application in the EU for generic Gilenya (fingolimod) capsules after the European Medicines Agency raised concerns that the company’s bioequivalence studies were “not reliable.”

The US firm also did not take “sufficient precautions” to prevent the formation of nitrosamines, known to be highly carcinogenic,...

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