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Mayne Pharma receives FDA approval for cancer drug

Mayne Pharma has received marketing authorization for its freeze-dried epirubicin product from the US Food & Drug Administration.

Epirubicin is a chemotherapy drug that is given as a treatment for many different types of cancer and is administered by injection. Epirubicin, sold under the brand name Ellence, generated sales of approximately $68 million in the US market.

“We are pleased to have received approval for this important oncology product at the formation of the market for generic epirubicin in the USA,” commented Dr Thierry Soursac, Mayne Pharma’s CEO and Managing Director

The company made the announcement after appealing for a trading halt before the market opened on September 19. The company said it was involved in discussions that could influence its share price in the market.

Mayne Pharma is an Australian pharmaceutical company specifically focused on manufacturing generic products for the oncology market.