Atopis eczema cream gets FDA OTC Status in USA
MD Magazine runs Atopis FDA story – “Novel, Natural Eczema Cream Gets FDA OTC registration”
December 1, 2017
Leading USA MD Magazine has picked up on the Atopis Press Release on the success in achieving US FDA OTC (Over-The-Counter) status for Atopis cream – Click the press release link to see the MD story:
A press release regarding the approval was made available.
Our press release reads:
FOR IMMEDIATE RELEASE: November 2017
A cream made from natural New Zealand ingredients clinically proven to treat eczema is set to help millions of American sufferers, after achieving OTC (over the counter) status for the US market.
Atopis’ Eczema Therapy Cream has been seven years in the making and will soon be sold online to American customers after meeting OTC regulatory requirements set by the US Food and Drug Administration.
This US OTC Status is believed to be a first for a New Zealand-made pharmaceutical product, and opens up a multi-billion dollar market.
Clinical trials in the US and New Zealand showed the cream – so natural you can eat it – successfully treats eczema without containing any parabens, solvents or steroids.
The cream is the culmination of knowledge amassed from more than 30 years of research and pharmaceutical development by Auckland scientist Dr Iona Weir, CEO of Bionona.
“It’s taken a long time to get here, but it is just so rewarding to know I have created a natural
product that is scientifically proven to help people, and now we are going into America – it can
help even more. The OTC Status is a coup for our company as well as for New Zealand”.
She’s used mainly native ingredients from her surroundings in the Waitakere forests for the eczema cream and a patented method, similar to fermentation, to extract nutrients from ingredients including bee pollen, coconut, honeydew and bacteria grown in New Zealand forests.
“I wanted to create something completely natural, but that could still get proven results from robust clinical tests on humans. We’ve gone through the world’s most rigorous clinical testing to prove that this is a natural product which actually works.”
Dr Weir has worked to harness the natural cell repairing processes of plants to treat topical skin conditions.
“By opening up to one of the biggest markets in the world, a New Zealand-made product can now help people treat their eczema with a clinically-proven, natural product. Eczema treatment is a multi-billion dollar market in the US and we have a world-leading product.”
Not only did the company have to meet the FDA’s strict criteria for the Over The Counter criteria, but it also had to prove its accredited status to Amazon, which it will sell through.
Eczema Therapy Cream will replace the Dry Itchy Skin Cream in the brand’s line of three products.
The new cream has a slightly different recipe to the older version which has been sold on the Atopis website along with the brand’s Acne Prone Skin Care and Anti-Aging Cream.
The new Eczema Therapy Cream will be available online in early February.
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