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2002 JUL 9 - (NewsRx.com & NewsRx.net) -- Avanir Pharmaceuticals (AVN) announced that the Ministry of Health in Israel has approved the company's docosanol 10% cream for marketing as a topical treatment for cold sores. Docosanol 10% cream will be marketed in Israel by CTS Chemical Industries under an exclusive license agreement that provides royalties to Avanir on wholesale product sales. CTS expects to begin marketing the product, which it will sell under the trade name "Abrax", in October 2002. The Avanir-developed product received non-prescription status, which allows the product to be sold over-the-counter (OTC).
In addition, the Korea Food and Drug Administration (KFDA) has approved docosanol 10% cream for marketing as a topical treatment for cold sores. Boryung Pharmaceuticals will market docosanol 10% cream in Korea under an exclusive license agreement that provides royalties to Avanir based on wholesale product sales. Boryung has reported that it expected to begin marketing the product under the trade name "Herepair" near the end of June 2002.
The Canadian Therapeutic Products Directorate (TPD) has issued a Notice of Compliance for docosanol 10% cream (Abreva) as a topical treatment for cold sores.
Docosanol has been approved for marketing in the U.S. and is pending a decision in Europe.
"[Israel] is the third OTC marketing approval for docosanol 10% cream that we have received this month," said Gerald J. Yakatan, PhD, president and CEO of Avanir Pharmaceuticals. "We are very pleased that CTS and our other licensees were successful in obtaining OTC status. The ability of consumers to have direct access to the product should allow for faster and more effective treatment for cold sore sufferers. This approval is another step in our strategy to enhance shareholder value by expanding ...
Source: HighBeam Research, Avanir's docosanol cream approved for marketing in Israel, Korea, and...