FDA News

 

Tenapanor Nixed By FDA, Citing Deficiencies in Application

July 21, 2021

Citing deficiencies within the New Drug Application submitted for tenapanor for use in patients with chronic kidney disease, the US FDA issued a letter to Ardelyx noting these deficiencies “preclude discussion” related to labeling and post-marketing requirements.

Roxadustat Receives Negative Vote from FDA Panel Ahead of PDUFA Date

July 19, 2021

The FDA's CRDAC July 15 meeting concluded with committee members voting against recommending the approval of roxadustat for the treatment of anemia in adult patients with chronic kidney disease not on dialysis and on dialysis.

Medtronic Halts Sale of HVAD System, FDA Issues Warning to Stop New Implants

June 04, 2021

After receiving more than 100 complaints, including some involving death, Medtronic has halted sale of the HeartWare Ventricular Assist Device System and the FDA has issued a warning to clinicians to stop new implants of the device.

Rosuvastatin/Ezetimibe Combination Therapy Approved for Lowering LDL-C

April 05, 2021

Althera Pharmaceuticals announced the FDA approved rosuvastatin and ezetimibe (Roszet) as an adjunct to diet for lowering LDL-C in adults patients with primary non-familial hyperlipidemia or homozygous familial hypercholesterolemia.