New Zealand's Douglas Pharmaceuticals announced today it had gained Food and Drug Administration (FDA) approval to sell its NZ-developed acne medication, isotretinoin, in the United States.

The company has been trying for around 10 years to break into the US acne medication market which is currently worth around US$400 million (NZ$494 million).

"This is a huge breakthrough for us and for New Zealand which will benefit from the increased export earnings," explains Douglas Pharmaceuticals director, Jeff Douglas. 

"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. The US market has, however, taken a little longer to get approval but as the US is the largest pharmaceutical market in the world the potential for us is very exciting."

Douglas says the company recently conducted clinical research to extend the product's use to other indications.

"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 says the first US orders will be despatched next month and a consumer launch is likely around April-May.

Isotretinoin is sold as a prescription-medicine in New Zealand under the brand name Oratane ®.

The company currently has another three NZ-developed products under review by the FDA.