After a decade of attempts to break into the US acne medication market, Douglas Pharmaceuticals has gained Food and Drug Administration (FDA) approval to sell its New Zealand-developed acne drug, isotretinoin.
It's a market worth US$400 million ($494 million), the company says, and the first US orders will be dispatched next month with a consumer launch to follow around April-May.
“This is a huge breakthrough for us and for New Zealand which will benefit from the increased export earnings,” said 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.”
Isotretinoin is sold as a prescription-medicine in New Zealand under the brand name Oratane.
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 Pharmaceuticals currently has another three locally-developed products under review by the FDA.
Founded in 1967 by managing director Sir Graeme Douglas, it has export turnover of more than $85 million from 15 different generic products, sold to 60 companies in 35 countries.