The FDA has approved use of Kcentra (CSL Behring), a human-derived 4-factor prothrombin complex concentrate (PCC), for urgent reversal of warfarin anticoagulation in adults with acute major bleeding. It is the only 4-factor PCC available in the US.

The FDA has approved changes to the labeling of Sublocade (Indivior), an extended-release formulation of the partial opioid agonist buprenorphine, to permit faster initiation and use of alternative injection sites. Sublocade is indicated for once-monthly subcutaneous treatment of moderate to severe opioid use disorder.

The FDA has approved insulin lispro-aabc (Lyumjev – Lilly), a faster-acting formulation of insulin lispro (Humalog), for treatment of type 1 and type 2 diabetes in adults. Fiasp, a faster-acting formulation of insulin aspart (Novolog), was approved in 2017.

The FDA has approved an inhaled, rapid-acting, dry-powder formulation of recombinant human insulin (Afrezza – Mannkind/Sanofi) for treatment of adults with type 1 or type 2 diabetes. In patients with type 1 diabetes, the drug must be used in combination with long-acting insulin. Another inhaled, rapid-acting insulin (Exubera) was approved in 2006 for the same indication, but was withdrawn from the market the following year.

The FDA has approved Fiasp (Novo Nordisk), a new formulation of insulin aspart, to improve glycemic control in adults with diabetes. Fiasp is described by the manufacturer as faster-acting than conventional insulin aspart (Novolog).

Rocuronium bromide (Zemuron - Organon), a new short-onset, intermediate-acting, nondepolarizing neuromuscular blocking drug, is now available in the USA for intravenous use. It is being promoted particularly for use in rapid endotracheal intubation.

The FDA has approved sebelipase alfa (Kanuma – Alexion), a recombinant form of lysosomal acid lipase (LAL), for enzyme replacement therapy in patients with LAL deficiency. Sebelipase alfa is the first drug to be approved in the US for treatment of LAL deficiency, a rare autosomal recessive storage disease.

An inhaled, dry-powder formulation of rapid-acting human insulin (Exubera - Pfizer) has been approved by the FDA for treatment of adults with type 1 or type 2 diabetes.

Hypertensive emergencies include hypertensive encephalopathy, intracranial hemorrhage with hypertension, aortic dissection, acute pulmonary edema with hypertension, acute cardiac ischemia with hypertension, malignant hypertension and severe hypertension after vascular surgery; hypertensive crisis due to pheochromocytoma or occurring during pregnancy is not discussed in this review. Although immediate reduction of blood pressure is necessary in hypertensive emergencies, an excessive decrease may cause stroke, myocardial infarction or visual changes. Most experienced clinicians aim...

The FDA has approved degarelix (Firmagon - Ferring), a synthetic decapeptide gonadotropin-releasing hormone (GnRH) receptor antagonist, for rapid medical castration of men with advanced prostate cancer. Abarelix (Plenaxis), the first GnRH antagonist approved by the FDA, was withdrawn from the US market because of immediate hypersensitivity reactions.