Secondary Hyperparathyroidism/Hypocalcemia

First New Drug for Secondary HPT in Over a Decade Gets FDA Approval

By February 08, 2017

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

By November 28, 2016

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

By September 19, 2016

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

By June 21, 2016

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

By March 30, 2016

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

By July 29, 2015

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

By May 29, 2015

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

By April 01, 2015

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

By January 26, 2015

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.

Hospira Launches Generic Zemplar Injection

November 06, 2014

Hospira announced the launch of Paricalcitol Injection, the generic version of AbbVie's Zemplar.

Rayaldee Efficacious in Secondary Hyperparathyroidism Trial

September 23, 2014

OPKO Health announced top-line results from the final Phase 3 trial of Rayaldee for the treatment of secondary hyperparathyroidism (SHPT) in patients with Stage 3 or 4 chronic kidney disease (CKD) and vitamin D insufficiency.

Positive Results for AMG 416 in Secondary Hyperparathyroidism Trial

August 19, 2014

Amgen announced results from its Phase 3 study evaluating AMG 416 for the treatment of secondary hyperparathyroidism in patients with chronic kidney disease (CKD) receiving hemodialysis.

Positive Phase 3 Results in Secondary Hyperparathyroidism with AMG 416

July 18, 2014

Positive Phase 3 results announced for AMG 416 (Amgen) for the treatment of secondary hyperparathyroidism in patients with chronic kidney disease (CKD), receiving hemodialysis.

Dr. Reddy's Launches Generic Zemplar

June 25, 2014

Dr. Reddy's Laboratories announced the launch of Paricalcitol Capsules, the generic version of AbbVie's Zemplar.

Generic Zemplar Capsules Available from Teva

October 01, 2013

A generic equivalent to Zemplar (paricalcitol; AbbVie) Capsules has been made available by Teva Pharmaceuticals.

Growth Hormone Ups Height in Pediatric Dialysis Patients

April 08, 2013

For pediatric dialysis patients, growth hormone therapy is associated with an increased rate of bone formation and results in greater increases in height.

Sensipar Pediatric Clinical Trials Suspended

February 26, 2013

The FDA has stopped all pediatric clinical trials of Sensipar (cinacalcet HCl; Amgen) after a recent death of a 14-year-old patient in a trial.