MAYNE Pharma has reacted to the US Food and Drug Administration’s (FDA) announcement that it will remove “black box” warnings from menopause hormone therapy products (PD 12 Nov), suggesting it will increase use of its products.

The company is currently in negotiations for a sale to US company Cosette Pharmaceuticals, which is subject to approval by the Foreign Investment Review Board.

“We welcome the FDA’s decision to remove outdated regulatory barriers that have discouraged the use of hormone therapies for symptomatic menopausal women,” said Mayne Pharma’s CEO and Manager Director Shawn O’Brien.

“Over time, we believe this change will make a meaningful difference in the ulitsation of Mayne pharma’s existing HRTs, namely Bijuva and Imvexxy.

“The company remains committed to expanding the use of our branded Women’s Health portfolio, driving commercial execution and delivering greater value for patients,” he added.

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