FDA News

Anemia Indication Sought for Phosphate Binder

Anemia Indication Sought for Phosphate Binder

Company asks FDA to approve ferric citrate for iron deficiency anemia in patients with non-dialysis dependent chronic kidney disease.

First Drug Approved to Treat Nocturnal Polyuria

First Drug Approved to Treat Nocturnal Polyuria

Noctiva is taken 30 minutes before bed and is designed to increase absorption of water through the kidneys.

Nivolumab Approved for Refractory Urothelial Carcinoma

Nivolumab Approved for Refractory Urothelial Carcinoma

The drug is indicated for treating patients with locally advanced or metastatic disease that progresses despite platinum-containing chemotherapy.

Bladder Cancer-Pioglitazone Link Reasserted by FDA

Bladder Cancer-Pioglitazone Link Reasserted by FDA

After analyzing new data, the FDA again warns that the diabetes drug may be associated with an increased risk for bladder cancer.

FDA Approves Removal of Boxed Warning for Hyperkalemia Drug

FDA Approves Removal of Boxed Warning for Hyperkalemia Drug

Updated label for patiromer now recommends the drug be taken at least 3 hours before or after other oral medications.

FDA Adds Abuse Warning to All Testosterone Products

FDA Adds Abuse Warning to All Testosterone Products

The new FDA warning alerts prescribers to the abuse potential of testosterone.

FDA Adds New Testosterone Warnings

FDA Adds New Testosterone Warnings

Labeling changes will alert prescribers to the abuse potential of testosterone and the serious adverse effects.

FDA Approves Enzalutamide Labeling Update

FDA Approves Enzalutamide Labeling Update

Labeling information will include data showing the drug reduces the risk of radiographic progression versus bicalutamide.

FDA Approving More Abuse-Deterrent Opioids

FDA Approving More Abuse-Deterrent Opioids

While ADFs of opioids may help mitigate the risk of opioid abuse, they have limitations as well.

FDA Approves Adlyxin to Treat Type 2 Diabetes

FDA Approves Adlyxin to Treat Type 2 Diabetes

Once-daily injection to improve glycemic control, along with diet and exercise.

FDA Adds Safety Warnings to Fluoroquinolones

FDA Adds Safety Warnings to Fluoroquinolones

Fluoroquinolones such as Cipro, Levaquin should be reserved for life-threatening infections.

FDA Approves First Absorbable Stent for CAD

FDA Approves First Absorbable Stent for CAD

The Absorb GT1 Bioresorbable Vascular Scaffold System (BVS) is absorbed by the body after about 3 years.

New Drug Cleared to Treat SHPT in Chronic Kidney Disease Patients

New Drug Cleared to Treat SHPT in Chronic Kidney Disease Patients

Calcifediol formulation is indicated for CKD stage 3 or 4 patients with secondary hyperparathyroidism associated with vitamin D insufficiency.

FDA Strengthens AKI Warning for Some SGLT2 Inhibitors

FDA Strengthens AKI Warning for Some SGLT2 Inhibitors

The Food and Drug Administration (FDA) announced it is strengthening the current warning about the risk of acute kidney injury for drug products containing canagliflozin (Invokana, Invokamet) and dapagliflozin (Farxiga, Xigduo XR).

Food Industry Needs to Reduce Sodium, FDA Says

Food Industry Needs to Reduce Sodium, FDA Says

The FDA has developed 2- and 10-year goals to reduce sodium content in both processed and prepared foods.