FDA delays approval of IntelGenx, RedHill migraine product


The FDA has told IntelGenx (IGXT) and RedHill Biopharma (RDHL -2.8%) that it won't yet approve their VersaFilm oral film treatment for acute migraines, due to issues over third party manufacturing, packaging and labeling.

However, in a complete response letter, the FDA said it accepted the bioequivalence study and safety information submitted, and that it requires no additional studies.

IntelGenx and RedHill intend to address the FDA's concerns within weeks, and to advance discussion with potential partners for the commercialization of VersaFilm.

In addition to seeking FDA approval for the product, IntelGenx and RedHill intend to file for European authorization later this year. (PR)

Comments (5)
  • joshihotels
    , contributor
    Comment (1) | Send Message
     
    IGXT stock price has tremendously upside due to news and strong possibility of a $3-5 buyout. Great Stock to buy on the way up.
    4 Feb 2014, 12:12 PM Reply Like
  • roboterotze
    , contributor
    Comments (14) | Send Message
     
    You read the bad news today, or ?

     

    At first IntergenX will lose 3,4,5,6 (?) weeks until the final approval..
    4 Feb 2014, 04:31 PM Reply Like
  • villagorgona
    , contributor
    Comments (14) | Send Message
     
    we overcome the big setback ,its buy stock no doubt.
    4 Feb 2014, 07:13 PM Reply Like
  • alikhan2006
    , contributor
    Comment (1) | Send Message
     
    Most likely third party manufactering issues is going to be resolved. Be optimist!
    17 Feb 2014, 05:51 PM Reply Like
  • docrog123
    , contributor
    Comments (150) | Send Message
     
    Of course we are never happy when there is FDA rejection or postponement but of all the possible reasons this happens, typo/clerical errors or third party are the two almost relief reasons for postponement. I just want the FDA to put the hammer down and end this elongated process. Imagine being in the hospital awaiting approval and this happens?
    21 Jul 2014, 03:53 AM Reply Like
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