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Spinraza Approval History

  • FDA approved: Yes (First approved December 23rd, 2016)
  • Brand name: Spinraza
  • Generic name: nusinersen
  • Dosage form: Injection
  • Company: Biogen
  • Treatment for: Spinal Muscular Atrophy

Spinraza (nusinersen) is a survival motor neuron-2 (SMN2)-directed antisense oligonucleotide indicated for the treatment of spinal muscular atrophy (SMA) in pediatric and adult patients.

Development History and FDA Approval Process for Spinraza

DateArticle
Dec 23, 2016Approval FDA Approves Spinraza (nusinersen) for Spinal Muscular Atrophy
Oct 28, 2016Biogen’s Regulatory Applications for Nusinersen as a Treatment for Spinal Muscular Atrophy Accepted by FDA and EMA
Sep 26, 2016Biogen Completes Rolling Submission of New Drug Application to FDA for Nusinersen as a Treatment for Spinal Muscular Atrophy

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