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Thread: Mirvaso has been approved by the FDA.

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  1. #1

    Default Mirvaso has been approved by the FDA.

    News today that Galderma has succeeded in gaining FDA Approval for Mirvaso – the brand name chosen for the product that during development was known as Sansrosa, CD07805/47 and Col-118.

    The Brimonidine Tartrate 0.33% Topical Gel is expected to be available as soon as next month.

    Great news that approval has been granted after so many years of waiting for rosacea sufferers following the development of this product.


    Galderma Receives FDA Approval of Mirvaso: the First and Only FDA-Approved Topical Treatment Specifically Developed and Indicated for the Facial Erythema of Rosacea

    Mirvaso Works Quickly and Lasts up to 12 Hours

    FT. WORTH, Texas--(BUSINESS WIRE)--Galderma Laboratories, L.P. today announced that the U.S. Food and Drug Administration (FDA) has approved Mirvaso (brimonidine) topical gel, 0.33% for the topical treatment of the facial erythema (redness) of rosacea in adults 18 years of age or older. Applied once daily, Mirvaso works quickly to reduce the redness of rosacea and lasts up to 12 hours. Galderma expects Mirvaso to be available in pharmacies September 2013.

    The approval of Mirvaso was based on data collected from more than 550 patients enrolled in two phase 3 clinical studies of one-month duration. The results from both studies showed that adults who used Mirvaso demonstrated significantly greater improvement in the facial redness of rosacea than vehicle gel. In addition, a long-term study in 276 subjects who used Mirvaso for up to 12-months was also conducted. Mirvaso is a topical gel that may work by constricting the dilated facial blood vessels to reduce the redness of rosacea. Mirvaso should be applied in a pea-sized amount, once daily to each of the five regions of the face: the forehead, chin, nose and each cheek.
    Note the Safety Information

    Important Safety Information - Mirvaso® Gel

    Indication: Mirvaso® (brimonidine) topical gel, 0.33% is an alpha-2 adrenergic agonist indicated for the topical treatment of persistent (nontransient) facial erythema of rosacea in adults 18 years of age or older.

    Adverse Events: In clinical trials, the most common adverse reactions (≥1%) included erythema, flushing, skin-burning sensation and contact dermatitis.

    Warnings/Precautions: Mirvaso gel should be used with caution in patients with depression, cerebral or coronary insufficiency, Raynaud's phenomenon, orthostatic hypotension, thromboangiitis obliterans, scleroderma, or Sjögren’s syndrome. Alpha-2 adrenergic agents can lower blood pressure. Mirvaso gel should be used with caution in patients with severe or unstable or uncontrolled cardiovascular disease. Serious adverse reactions following accidental ingestion of Mirvaso gel by children have been reported.

    Keep Mirvaso gel out of reach of children. Not for oral, ophthalmic, or intravaginal use.

    You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
    Get Rosacea News here - https://rosacea-support.org

  2. #2
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    Default What a great news

    Hi that's great news, I've been waiting this for a long long time, I wonder when it would be available in South America.

    I hope this can be the final solution to my persistent redness.


    Greetings from Ecuador

  3. #3
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    Great news! I have been tracking the progress of Mirvaso for around 7 years! This is a timely boost, as my skin has been in very poor condition recently. Any ideas what countries it will be available in first?

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    Does anyone know if this is only for permanent redness or will it help for redness that comes and goes?

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    all aboard the hype train. Hopefully i can avoid any more v-beams now :P

    However from everything id read previously it indicated that if it were successful in the trial that earliest release would most likely be 1st quarter 2014, but they're stating it will be hopefully be in pharmacies in September 2013. Does that seem a little too hopeful?
    Last edited by maskielli; 26th August 2013 at 11:12 PM.

  6. #6
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    This sounds promising for someone whose only symptom is erythema. After no success with finacea or metrogel I have doubted any topical medication being effective, what makes this different?

  7. #7

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    Quote Originally Posted by maskielli View Post
    However from everything id read previously it indicated that if it were successful in the trial that earliest release would most likely be 1st quarter 2014, but they're stating it will be hopefully be in pharmacies in September 2013. Does that seem a little too hopeful?
    No it has been granted official approval and will be available in the US from next month.
    Get Rosacea News here - https://rosacea-support.org

  8. #8

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    Quote Originally Posted by cricket0117 View Post
    Does anyone know if this is only for permanent redness or will it help for redness that comes and goes?
    Officially it is for non-transient redness, i.e. not the sort of redness that comes and goes with a flush.
    Get Rosacea News here - https://rosacea-support.org

  9. #9
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    Quote Originally Posted by David Pascoe View Post
    Officially it is for non-transient redness, i.e. not the sort of redness that comes and goes with a flush.
    However, if Mirvaso acts by constricting blood vessels, I don't see that it wouldn't help with flushing at all. I really hope it will.

  10. #10
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    Default juvenile rosacea

    Quote Originally Posted by David Pascoe View Post
    Officially it is for non-transient redness, i.e. not the sort of redness that comes and goes with a flush.
    My 9 year old daughter has been diagnosed with juvenile rosacea by her dermatologist. Is Mirvaso stictly for adults? Do you have any suggestions on how a child can best reduce the persistent facial flushing? We have also seen a pediatric rheumatologist at UCSF and they have ruled out Lupus, etc...

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