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Drug news

Sarepta to file rolling NDA submission at FDA for eteplirsen to treat Duchenne muscular dystrophy .

Read time: 1 mins

Last updated:20th May 2015

Published:20th May 2015

Source: Pharmawand

Sarepta Therapeutics, announced that the Company held a pre-New Drug Application (NDA) meeting with the FDA regarding its lead product candidate, eteplirsen, for the treatment of Duchenne muscular dystrophy (DMD). Sarepta has agreed with the Agency to initiate a rolling NDA submission and will submit the non-clinical and CMC components of the NDA by the end of this week. As previously announced, Sarepta plans to submit the final component of the NDA by mid-year 2015.

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