Aprela® — the making of a new pregnant mare’s urine drug

1 Oct

Considering the governement shutdown that started today (October 1, 2013) does anyone know if the USDA is still functioning enough to approve or reject drugs scheduled for a decision this week? The previous government shutdown lasted for several weeks. The only part of the USDA that I know of that is still functioning during the shutdown is for meat inspection.

Tuesday's Horse

Part 1 of a Special Report by Jane Allin

Pfizer and Ligand logos united with pee and blood drops.

October 3, 2013 looms as the harbinger of foreboding news for PMU mares and their foals.

This is the day that the U.S. Food and Drug Administration (FDA) will make a decision whether or not to approve Ligand Pharmaceutical’s dual-acting drug Aprela® for the treatment of menopausal symptoms and prevention of postmenopausal osteoporosis in women who have not undergone a hysterectomy. The drug was developed by Ligand in partnership with Pfizer.

Aprela® is a combination of Premarin® and bazedoxifene, a selective estrogen receptor modulator or SERM also known as Viviant®. Of particular note is that Viviant® has failed to receive approval from the FDA as a result of increased risks of stroke and thromboembolic events although it has been approved for use in other countries (i.e. EU and Japan) under different trade names. What’s more, Pfizer/Wyeth’s struggle to gain approval of…

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