West Auckland-based Douglas Pharmaceuticals has gained approval to sell its acne medication in the United States, and says it is the first New Zealand-developed human medicine to be approved for use there.
Director Jeff Douglas said Food and Drug Administration approval for the drug - called isotretinoin - was a huge breakthrough for the firm, which had spent 10 years trying to enter the US$400 million ($494 million) acne medication market. "It's our biggest export product and is the market leader in Spain, Austria, Germany and Mexico," Douglas said.
The first orders would be sent to the US next month.
Isotretinoin is sold as a prescription medicine in New Zealand under the brand name Oratane.
The company said another three products developed here were being reviewed by the FDA.
Douglas, the largest locally-owned pharmaceutical company, was founded in 1967 by its managing director, Sir Graeme Douglas.
It has an annual domestic revenue of $57 million, while its export revenue has grown to more than $85 million from 35 countries, according to Trade and Enterprise.