Get the free Exondys 51 (eteplirsen) FDA Approval History - Drugs.com
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CENTER FOR DRUG EVALUATION AND RESEARCH
Approval Package for:
APPLICATION NUMBER:
206488Orig1s000
Trade Name:Exodus 51 Injection, 50 mg per generic or Proper Name:eteplirsenSponsor:Santa Therapeutics,
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Who needs exondys 51 eteplirsen fda?
01
Exondys 51 eteplirsen FDA is typically needed by patients diagnosed with Duchenne muscular dystrophy (DMD) who have a confirmed mutation amenable to exon 51 skipping.
02
This medication is specifically indicated for individuals who are ambulatory.
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What is exondys 51 eteplirsen fda?
Exondys 51 (eteplirsen) FDA is a drug used for the treatment of Duchenne muscular dystrophy.
Who is required to file exondys 51 eteplirsen fda?
The pharmaceutical company that manufactures Exondys 51 (eteplirsen) is required to file with the FDA for approval and regulation.
How to fill out exondys 51 eteplirsen fda?
The pharmaceutical company must submit all necessary documentation and data to the FDA for review and approval.
What is the purpose of exondys 51 eteplirsen fda?
The purpose of Exondys 51 (eteplirsen) FDA is to provide a treatment option for patients with Duchenne muscular dystrophy.
What information must be reported on exondys 51 eteplirsen fda?
The pharmaceutical company must report clinical trial data, safety information, and efficacy results for Exondys 51 (eteplirsen) to the FDA.
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