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Thread: New SD Product (Dermadexin)

  1. #21
    Senior Member
    Join Date
    Dec 2015
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    183
    Country: Great Britain

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    Cipher Pharmaceuticals' website says it's still in the pipeline, and there's no mention of any kind of time frame for its release. A forum member contacted them directly and was told it's set for "spring of 2017", which is clearly fast approaching, but who knows for sure if they're even sticking to that. I think many of us have been interested in this for a while now, but their opaqueness and lack of readily available info are a tad frustrating -- 99% of the internet search results for Dermadexin turn up a stock market analysis for the company rather than any details about the product itself!

  2. #22
    Junior Member
    Join Date
    Oct 2012
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    14

    Default From latest Q4 report

    Excerpt taken from document available on cipher pharma website
    In Q3 2015, Cipher received an Acceptance Review Notification for its 510(k) submissions for both Dermadexin™ and Pruridexin™ to
    the FDA. The notification confirmed that the submission contained all of the necessary elements and information needed to proceed
    with the substantive review. The FDA put the review on hold due to the uncertainty of the functions of the ingredients. The FDA
    requested that Cipher submit a “Request for Determination” (“RFD”) to the Office of Combination Products to determine whether the
    products are considered drugs or devices. In April 2016, Cipher submitted an informal RFD for Dermadexin and received a non-binding
    regulatory determination that the product, which contained nicotinamide (a new ingredient not listed in the device database) should be reviewed under the jurisdiction of the Center for Drug Evaluation and Research (CDER). The Company is currently working with
    consultants to determine the regulatory pathway for Dermadexin and Pruridexin in the U.S.

    In April 2016, Cipher received Health Canada approvals (via Natural and Non-Prescription Health Products Directorate “NNHPD”) for
    DexiDerm SD Cream and DexiDerm AD Cream (also known as Dermadexin and Pruridexin) and is developing launch plans for the
    products in Canada. DexiDerm CD was approved by the NNHPD in August 2016 and DexiDerm Scalp was approved on November 3,
    2016.

    In Europe, Helioclin® Dermatitis SD Cream (also known as Dermadexin) was approved in Europe in 2014 and Helioclin® Pruritus SD
    Cream (also known as Pruridexin) was approved in April 2016, as a Class III medical device. Cipher is seeking partners in Europe for
    Pruridexin and Dermadexin.

  3. #23
    Senior Member
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    Dec 2015
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    183
    Country: Great Britain

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    So the delay is, unsurprisingly, from being stuck in bureaucratic limbo in the USA. Yet more proof that the FDA is horrendously broken.

    I wonder how nicotinamide (a.k.a. niacinamide/Vitamin B3) is a "new" ingredient not listed in their database -- it's a common ingredient in the cosmetic industry ever since Procter & Gamble started using it about 17 years ago.

    Dermadexin is potentially the first revolutionary treatment for SD in a long time and it might struggle to even launch.

  4. #24
    Junior Member
    Join Date
    Apr 2017
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    5

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    Product was ready in 2013 and still not available?

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