-
Acne medication Oratane - Source: Supplied
A New Zealand developed medication for acne has been approved for sale in America.
Douglas Pharmaceuticals, which was founded in 1967 by Sir Graeme Douglas, has announced today it has gained Food and Drug Administration (FDA) approval to sell its NZ-developed acne medication called isotretinoin, in the United States.
The company has been trying for around 10 years to break into the US acne medication market which it estimates is currently worth around $US400 million (NZ$494 million).
"This is a huge breakthrough for us and for New Zealand which will benefit from the increased export earnings," Douglas Pharmaceuticals director, Jeff Douglas said.
"We believe our isotretinoin is the first NZ-developed human medicine to be approved for use in the US.
"It's our biggest export product and is the market leader in Spain, Austria, Germany and Mexico.
"Isotretinoin is sold as a prescription-medicine in New Zealand under the brand name Oratane."
Douglas said the US market took longer to approve the drug than other countries but the market potential is "very exciting" as the US is the largest pharmaceutical market in the world.
The company has recently conducted clinical research to try and extend the product's use.
"Although the product has been around for about 30 years, we've been coming up with new ways to use it. It's normally indicated for the treatment of moderate to severe acne," Douglas said.
Douglas Pharmaceuticals expects the first US orders will be despatched next month and a consumer launch is likely around April-May.
The company currently has another three NZ-developed products under review by the FDA.
