NZ acne medication wins US approval
Kiwi company Douglas Pharmaceuticals has won approval to sell its locally developed acne medication in the United States.
The Auckland-based company has been trying for a decade to break into the US acne medication market, currently worth about US$400 million ($494 million). Its new medication isotretinoin now has Food and Drug Administration (FDA) approval.
The company is New Zealand's largest manufacturer of pharmaceuticals, specialises in immuno-suppression, central nervous system, oncology and dermatology products. It already sells to 35 countries, with an export turnover of $85m.
Director Jeff Douglas said in a statement that it was a huge breakthrough and would boost export earnings. It believes it is the first New Zealand-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,'' he said.
''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.''
While the product had been around for 30 years, the company had examined new ways to use it.
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 locally developed products under review by the FDA.