Bone Care Injectable Hectorol Approved After "Filing Over Protest"
This article was originally published in Pharmaceutical Approvals Monthly
Bone Care International’s "file-over-protest" strategy for injectable Hectorol (doxercalciferol) resulted in approval of the vitamin D replacement therapy on April 6, exactly one year after the NDA was submitted over FDA’s objection.
You may also be interested in...
Redeeming a priority review voucher obtained by developing a drug for a tropical disease will cost companies $6.1 million in fiscal 2011
The paradoxical finding that Dendreon's cancer immunotherapeutic Provenge (sipuleucel-T) improved overall survival in men with metastatic castration-resistant prostate cancer but did not appear to slow the progression of the disease is raising questions about the future of clinical development for the burgeoning class