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Titan Pharmaceuticals Inc. Message Board

  • jttarbel jttarbel Oct 29, 2012 10:36 AM Flag

    Un Fn Believable....

    We get our NDA news today....On the only day since 2001 the markets are forced to be closed!
    We'll see what happens tomorrow. GLTA TRUE LONGS

    Sentiment: Strong Buy

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    • Just a hunch because of this:

      "Because there are numerous NDA and ANDA products in the buprenorphine class, in the interest of public health and to reduce the burden on the healthcare system of multiple unique REMS programs, we have determined that a single, shared system to implement these REMS programs is needed. You must contact the sponsor of the reference listed drug for your ANDA, Reckitt Benckiser Pharmaceuticals Inc., regarding the development of the single shared system,” the FDA wrote to generic drugmakers last year (here is the excerpt).

      For months, though, this effort has stalled, according to industry sources, who tell us Reckitt has not given any indication that it will cooperate in designing such a REMS and has not shared some of the specifics with the generic drugmakers. “There are many components in their REMS, and these can be very stringent, but Reckitt won’t tell us what they are. They’ve seized upon this and used the situation to their advantage. And no progress has been made,” says a source."

      If you Google "generic suboxone" it should be the first article by Forbes.

      Maybe it only applies to the tablets, but it seems to deal with any Suboxone like product. If the partner is actively helping them with the REMS then it makes some sense that it is RB, right?

    • It was clearly a mistake...

      It isn't even on their website.

      It sucks, but it happened to Google a week or so ago.

      The important thing is that they got the NDA submitted and that the partner seems to be RB.

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