Expected FDA ruling on neostigmine fuels Flamel's uptrend

Shares of Flamel Technologies (FLML +15.7%) pop on a 5x surge in volume representing a tidy 450% gain from the December 2012 low of $2.85. The fuel for the uptrend is the expectation that the FDA will issue a ruling that will favor Flamel's Bloxiverz (neostigmine methysulfate injection).

Neostigmine was first synthesized in 1931, making it eligible for grandfathering when the FDA was established. No company had an approved NDA for the product until Flamel's in July 2013. The regulator typically removes unapproved products within one year after it clears an NDA. Bloxiverz will enjoy a period of exclusivity as a result. Approximately 5M vials of neostigmine are sold in the U.S. each year.

Comments (3)
  • mustardtree
    , contributor
    Comment (1) | Send Message
    check this FDA shortage update
    20 Jun 2014, 01:59 PM Reply Like
  • 911Slade
    , contributor
    Comments (134) | Send Message
    A proprietary neostigmine would be less likely to have such shortages due to the greater profits, and thus incentive to produce. And with recent Japanese reports of allergic reactions using Sugammadex that will slow the FDA again there is really no alternative.


    Once there is no generic competition watch the prices on this product go up as well as the available supply.


    Most generic drugs used in anesthesia are or have recently experienced shortages, including salt water (.9 normal saline) as the prices have been driven down to a minimal profit or even a loss.
    20 Jun 2014, 05:54 PM Reply Like
  • dow43
    , contributor
    Comments (6) | Send Message
    When could we expect a final decision from FDA about exclusivity to Eclat ?
    23 Jun 2014, 09:21 AM Reply Like
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