Amgen competitor Opko plans year-end NDA for Rayaldee
This article was originally published in Scrip
Opko Health will submit a new drug application (NDA) to the US FDA for Rayaldee (CTAP101) based on a second set of positive Phase III results in the treatment of secondary hyperparathyroidism (SHPT) in patients with stage 3 or 4 chronic kidney disease (CKD) and vitamin D insufficiency.
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