The FDA has approved a manually injected, single-dose, prefilled epinephrine syringe (Symjepi – Adamis/Sandoz) for emergency treatment of anaphylaxis. The new device is approved in 0.3- and 0.15-mg strengths for treatment of patients weighing ≥30 kg and 15 to 30 kg, respectively; only the 0.3-mg strength is currently available. According to Sandoz, Symjepi will be made available first to institutions and later to the retail market.

The antisense oligonucleotide viltolarsen (Viltepso – NS Pharma) has received accelerated approval from the FDA for treatment of Duchenne muscular dystrophy (DMD) in patients who have mutations of the dystrophin gene that are amenable to exon 53 skipping (DMD-53). It is the second drug to be approved for this indication; the antisense oligonucleotide golodirsen (Vyondys 53) was approved in 2019.

The FDA has approved Verkazia (Santen), a 0.1% ophthalmic emulsion formulation of the calcineurin inhibitor cyclosporine, for treatment of vernal keratoconjunctivitis (VKC). Verkazia is the first product to be approved in the US for this indication.

A reader who took the online continuing medical education (CME) exam for issue 1406 (Med Lett Drugs Ther 2012; 54:101) pointed out that the first question assumed that a rash following oral administration of ampicillin would be due to allergy. Perhaps we should have mentioned in our article on penicillin allergy that late-appearing maculopapular rashes associated with oral ampicillin or amoxicillin are generally considered non-allergic and need not preclude subsequent administration of ampicillin or amoxicillin.

The PCSK9 inhibitor evolocumab (Repatha – Amgen) is now available in a single-dose, hands-free device (Repatha Pushtronex) for once-monthly subcutaneous infusion. Evolocumab is FDA-approved as an adjunct to diet and maximally tolerated statin therapy for patients with heterozygous familial hypercholesterolemia (HeFH) or clinical atherosclerotic cardiovascular disease who require additional lowering of low-density lipoprotein cholesterol (LDL-C), and as an adjunct to diet and other LDL-lowering therapies for patients with homozygous familial hypercholesterolemia (HoFH).Evolocumab is also...

The FDA has approved defibrotide sodium (Defitelio – Jazz), a mixture of mostly single-stranded polydeoxyribonucleotide sodium salts, for treatment of adults and children with hepatic veno-occlusive disease (also known as sinusoidal obstruction syndrome) and renal or pulmonary dysfunction following hematopoietic stem cell transplantation (HSCT). It is the first drug to be approved by the FDA for treatment of severe hepatic veno-occlusive disease. Defibrotide was approved earlier by the European Medicines Agency for the same indication.Hepatic veno-occlusive disease is an uncommon (<2%)...

The androgen receptor inhibitor darolutamide (Nubeqa – Bayer) has been approved by the FDA for use in combination with docetaxel for treatment of metastatic hormone-sensitive prostate cancer (mHSPC). The drug was previously approved for treatment of nonmetastatic castration-resistant prostate cancer (nmCRPC).

immune globulin (human) has been available for many years in an intramuscular (IM) formulation for prevention of Rh isoimmunization in pregnant Rh-negative women (Medical Letter, 16:3, 1974). Recently, the US Food and Drug Administration (FDA) approved the first intravenous (IV) immune globulin preparation (WinRho SD - Univax), not only for preventing Rh isoimmunization, but also for treatment of immune thrombocytopenic purpura (ITP) in Rh-positive patients.

Tenecteplase, a recombinant variant of human tissue plasminogen activator, is now available for thrombolysis in patients with acute myocardial infarction.

Olmesartan medoxomil (Benicar - Sankyo), a substituted imidazole, is the seventh oral angiotensin II receptor blocker (ARB) approved by the FDA for treatment of hypertension.