‘Clinical Superiority’: FDA Finds Diazepam Nasal Spray Deserves Orphan Exclusivity

Discussion in 'Pharma/Biotech Companies - In the News' started by cafead, Jan 14, 2020 at 10:12 AM.

  1. cafead

    cafead Administrator
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    via Thanks to the last user fee agreement, known as the FDA Reauthorization Act of 2017, the agency can now explain why a newly approved orphan drug is clinically superior to previously approved orphan drugs and therefore should be awarded seven years of orphan drug exclusivity.

    Since 2017, FDA has only explained how five treatments can be considered clinically superior, with the latest coming last Friday for Neurelis Pharmaceuticals’ Valtoco (diazepam nasal spray). FDA explains how diazepam was previously approved as a gel administered rectally whereas Valtoco’s intranasal route of administration is easier to use.

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  2. anonymous

    anonymous Guest

    How does/will this compare with the UCB seizure spray? and is Neurelis hiring?? nothing on their website. My niece needs diastat for seizures, and it's not fun.
     
  3. anonymous

    anonymous Guest

    they got approval for their spray a few weeks ago. on their website under jobs it takes you to their linked in, with still no jobs listed?
     
  4. anonymous

    anonymous Guest

    the diazepam film was approved today... all of a sudden, a crowded market for epilepsy rescue meds
     
  5. anonymous

    anonymous Guest

    whos hiring. whos paying. which is the best of the 3?
     
  6. anonymous

    anonymous Guest

     
  7. anonymous

    anonymous Guest

    they all blow
     
  8. anonymous

    anonymous Guest

    the film was not "approved" - just a date was given for when it may get approval. im not sure how they can do that with the exclusivity period of Valtoco but who knows