Douglas Pharmaceuticals has received US regulatory approval to sell its acne medication in the $US494 million American market, after 10 years of trying.
The company says it obtained Food & Drug Administration approval for its isotretinoin product.
Douglas says the acne product is its biggest export and is the market leader in Spain, Austria, Germany and Mexico, but America is the largest pharmaceutical market in the world.
The first US orders will be sent next month and it will launch the product there in April or May.
The company says it has another three products under review by the US's Food and Drug Administration.