FDA Alerts

Since its inception in 2009, the FDA’s Safe Use Initiative has collaborated with these stakeholders to investigate new threats to patient safety and develop innovative programs to combat them.

The FDA has issued a warning based on 20 reported cases of ketoacidosis in patients using sodium-glucose co-transporter 2 inhibitors for type 2 diabetes.

The FDA has granted orphan drug designation to Humira for the treatment of moderate to severe hidradenitis suppurativa (HS; Hurley stage II and III).

The FDA has approved a new option for the treatment and prevention of pneumonic and septicemic plague.

The FDA has approved a new spinal cord stimulation system that helps patients manage chronic intractable pain.

The FDA has approved a generic version of Abilify, an injectable drug to reduce chin fat, and recalled hundreds of APIs from the United States.

The FDA has approved new options for the treatment of presbyopia and multiple sclerosis, and issued a recall after an outbreak of listeria.

The US Food and Drug Administration recently approved ivabradine to treat chronic heart failure caused by improper contracting of the left-ventricle and to reduce hospitalization.

The FDA has released its finalized industry guidance for the development of abuse-deterring opioid drugs.

The FDA approved the Impella 2.5 System to help stabilize circulation and heart function during high-risk percutaneous coronary intervention procedures.