The FDA has approved an epinephrine nasal spray (neffy – ARS Pharma) for emergency treatment of type 1 hypersensitivity reactions including anaphylaxis in patients who weigh ≥30 kg. It is the first noninjectable epinephrine product to be approved for this indication.

The FDA has approved Prestalia (Symplmed), an oral fixed-dose combination of the dihydropyridine calcium channel blocker amlodipine (Norvasc, and generics) and a new salt form of the angiotensin-converting enzyme (ACE) inhibitor perindopril, for treatment of hypertension in patients not adequately controlled on monotherapy or already taking both drugs, and in those just starting therapy who are likely to need multiple drugs to control their blood pressure. The new salt form (perindopril arginine) is more stable and has a longer shelf-life than perindopril erbumine (Aceon, and...

The FDA has approved elvitegravir (Vitekta – Gilead), an integrase strand transfer inhibitor (INSTI), for use with a protease inhibitor (PI) plus ritonavir and other antiretroviral drugs for treatment of HIV-1 infection in treatment-experienced adults. Elvitegravir is also available in a fixed-dose combination (Stribild) with the pharmacokinetic enhancer cobicistat and the nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs) emtricitabine and tenofovir disoproxil fumarate (DF). A similar combination (Genvoya) that includes tenofovir alafenamide instead of tenofovir...

The FDA has warned that the antiepileptic and mood-stabilizing drug lamotrigine (Lamictal, and generics) can rarely cause hemophagocytic lymphohistiocytosis (HLH), a serious and potentially fatal immune-related reaction.1HLH, which can be familial, occurs most often in infants, but can occur at any age. Often induced by Epstein-Barr Virus infection (HIV infection and non-Hodgkin's lymphoma are other common triggers), HLH is characterized by an unremitting activation of CD8+ T cells and macrophages.2 If untreated, it causes organ damage, particularly in the liver, bone marrow, and CNS; organ...

The FDA has approved intravenously administered recombinant von Willebrand factor (Vonvendi - Shire) for adults with von Willebrand disease (VWD) who require on-demand treatment and control of bleeding episodes. It is the first recombinant von Willebrand factor (VWF) product to become available in the US.

Atrial fibrillation increases the risk of thromboembolic stroke. Anticoagulant therapy can reduce this risk and is recommended for patients with atrial fibrillation and one or more of the following: congestive heart failure, hypertension, age ≥75 years, diabetes, or prior stroke or transient ischemic attack (CHADS₂ score ≥1).

The FDA has approved Cinvanti (Heron), an IV emulsion formulation of the substance P/neurokinin-1 (NK1) receptor antagonist aprepitant, for prevention of acute and delayed chemotherapy-induced nausea and vomiting (CINV) in adults. Aprepitant is also available in oral capsule and suspension formulations (Emend, and generics), and fosaprepitant, a prodrug of aprepitant, is available in an IV formulation (Emend for injection).

A combination of the corticosteroid budesonide and the long-acting beta₂-agonist formoterol (Symbicort - AstraZeneca) has become available in a metered dose inhaler for long-term maintenance treatment of asthma in patients ≥ 12 years old. A combination product that contains fluticasone propionate and salmeterol (Advair) is already available for this indication in the US. Neither one of these combinations is approved for acute treatment of asthma symptoms. A dry powder inhaler formulation of Symbicort has been available in Europe and Canada for several years.

The FDA has approved dolutegravir (doll-you-TEG-rah-veer; Tivicay – Viiv Healthcare), an integrase strand transfer inhibitor (INSTI), for treatment of HIV-1 infection in adults and in children ≥12 years old who weigh at least 40 kg. It is the third INSTI to be approved by the FDA; raltegravir and elvitegravir were approved earlier.

The FDA has approved the sodium/hydrogen exchanger 3 (NHE3) inhibitor tenapanor (Xphozah – Ardelyx) to reduce serum phosphorus in adults with chronic kidney disease (CKD) on dialysis as add-on therapy when phosphate binders are ineffective or as monotherapy when phosphate binders cannot be tolerated. Tenapanor is the first NHE3 inhibitor to be approved in the US for hyperphosphatemia. It was previously approved as Ibsrela to treat irritable bowel syndrome with constipation (IBS-C).