CKD-Mineral and Bone Disorder Treatment Recommendations Updated
In addition, for adult patients with CKD G3a-G5 not on dialysis, the new guideline indicates that calcitriol and vitamin D analogs should not be routinely used.
Secondary Hyperparathyroidism/Hypocalcemia
First New Drug for Secondary HPT in Over a Decade Gets FDA Approval
Amgen announced that the Food and Drug Administration (FDA) has approved Parsabiv (etelcalcetide) for the treatment of secondary hyperparathyroidism in adults with chronic kidney disease (CKD) on hemodialysis.
Rayaldee Available for Treating Secondary Hyperparathyroidism
Opko Health announced that Rayaldee (calcifediol) extended-release capsules will be available in pharmacies as early as Wednesday, November 30.
Dr. Reddy’s Launches Generic Zemplar Injection
Dr. Reddy’s Laboratories announced the launch of Paricalcitol Injection, the generic version of AbbVie’s Zemplar.
Rayaldee Approved for Secondary Hyperparathyroidism in Adults with CKD
Opko Health announced that the Food and Drug Administration (FDA) has approved Rayaldee (calcifediol) extended-release capsules for the treatment of secondary hyperparathyroidism (SHPT) in adults with Stage 3 or 4 chronic kidney disease (CKD) and serum total 25-hydroxyvitamin D <30ng/mL.
Rayaldee Approval Process Halted Due to Third-Party Manufacturer Issues
The FDA has issued a Complete Response Letter (CRL) to the New Drug Application (NDA) for Rayaldee (calcifediol; Opko) as a treatment for secondary hyperparathyroidism (SHPT) in patients with Stage 3 or 4 chronic kidney disease (CKD) and vitamin D insufficiency.
Rayaldee NDA Accepted for SHPT in Stage 3 or 4 CKD and Vitamin D Deficiency
The Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for Rayaldee (calcifediol modified-release capsules, Opko) for the prevention and treatment of secondary hyperparathyroidism (SHPT) in patients with stage 3 or 4 chronic kidney disease (CKD) and vitamin D insufficiency.
Novel Agent AMG 416 Effective in Secondary Hyperparathyroidism Trials
Amgen announced pooled data from two Phase 3 trials evaluating AMG 416 for the treatment of secondary hyperparathyroidism (SHPT) in patients with chronic kidney disease (CKD) receiving hemodialysis.
New Parathyroid Hormone Injection Now Available
Shire announced the launch of Natpara (parathyroid hormone) for injection indicated as adjunct to calcium and vitamin D to control hypocalcemia in patients with hypoparathyroidism
Natpara Injection Approved for Hypocalcemia
The Food and Drug Administration (FDA) has approved Natpara (parathyroid hormone; NPS Pharmaceuticals) for injection as adjunct to calcium and vitamin D to control hypocalcemia in patients with hypoparathyroidism.
