However, Cowen said there are still “significant concerns” associated with prescribing separate estrogen and progesterone pills (non-compliance of the progesterone component can lead to increased risk for endometrial cancer), and therefore an U.S. Food and Drug Administration (FDA) approved combination of bioidentical estrogen and progesterone would be extremely well-received. “Additionally, with the passing of the Drug Quality and Security Act in 2013, compounding pharmacies will not be able to produce copies of TX-001HR once approved, suggesting that it could be the preferred product to capitalize on the $1.5 billion compounded hormone replacement therapy market opportunity,” said Cacciatore

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