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Catalyst Pharmaceuticals, Inc. Message Board

  • samyo1 samyo1 Oct 20, 2013 5:20 PM Flag

    Jacobus Hiding Something?

    I imagine Jacobus is getting a tax write-off.

    The daughter said herself that someone has to pay.

    The taxpayers are going to pay. Either through a tax subsidy to a known GMP violator with no monetary motivation to make sure the drug is safe like Jacobus, or to a company like CPRX who has every motivation to make sure the drug is made properly and safely.

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    • DAP is FDA approved for Jacobus and has been for over 20 years. Because it is an orphan drug it is probably more scrutinized by the FDA. Safety is not a question.

      • 3 Replies to ohfredoh
      • That would be weird to award Breakthrough Therapy status to CPRX for a drug that was already approved.

        Why would CPRX spend so much money proving a more stable compound salt of 3,4 DAP if it was already approved?

        The reason is because it is not already approved and Jacobus wasn't going to spend the money to approve their version probably because that would cost money and they could circumvent the FDA process for 20+years by using it as a tax write off instead.

        Safety is a big issue.

        .: Mid-Atlantic Region

        Food and Drug Administration
        J Waterview Corporate Center
        Telephone (201) 331–2906 10 Waterview Blvd., 3rd Floor
        F’arsippany, NJ 07054
        October 1, 1997
        Dr. David P. Jacobus
        Jacobus Pharmaceutical Co. , Inc.
        37 Cleveland Lane, PO Box 5290
        Princeton, New Jersey 08540
        File No.: 97-NWJ-52
        Dear Dr. Jacobus:
        During an inspection of your Manufacturing facility located at
        Schalks Crossing Road, Plainsboro, New Jersey 08536, between June
        n-July 3, 1997, one of our invest~gators documented significant
        deviations from current Good Manufacturing Practices (cGMPs) in the
        manufacture of Active Pharmaceutical Ingredients (APIs) and
        finished pharmaceuticals.
        The aforementioned inspection revealed that API products and
        finished pharmaceuticals manufactured and released at this facility
        are considered adulterated within the meaning of section 501(a) (2)
        (B) of the Federal Food, Drug & Cosmetic Act (the Act).
        Although the GMP regulations under Title 21 Code of Federal
        Regulations, Parts 210 and 211, are used as guidelines in the API
        industry, Section 501 (a) (2) (B) of the Act requires that all
        drugs be manufactured, processed, packed, and held in accordance
        with cGMPs. No distinction is made between active pharmaceutical
        ingredients and finished pharmaceuticals. Failure to comply with
        cGMPs constitutes a failure to comply with requirements of the Act.

      • 3,4 DAP is NOT an ORPHAN DRUG...Firdapse DOES HAVE FDA orphan drug status....

      • Jacobus does not have FDA approval for this drug. They get the FDA's approval to use it on a case by case basis, NOT even close to being the same thing.

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