An extended-release oral formulation of guanfacine hydrochloride (Intuniv – Shire), a selective alpha_2A-adrenergic agonist, has been approved by the FDA for treatment of attention-deficit/hyperactivity disorder (ADHD) in children 6-17 years old.

The Medical Letter recently reviewed a topical gel formulation of testosterone (Fortesta) for treatment of hypogonadism in men. A topical testosterone replacement product for application to the axilla, Axiron (Lilly) solution, has now become available for the same indication. This site of application presumably minimizes the risk of transferring the drug to a family member or sexual partner.

The FDA has approved tafluprost ophthalmic solution (Zioptan – Merck), a prostaglandin analog, for reduction of intraocular pressure in patients with open-angle glaucoma or ocular hypertension. It is being marketed as the first preservative-free topical prostaglandin

Ziv-aflibercept (Zaltrap – Sanofi/Regeneron), a vascular endothelial growth factor (VEGF) inhibitor, has been approved by the FDA for use in combination with 5-fluorouracil, leucovorin and irinotecan (FOLFIRI) for treatment of metastatic colorectal cancer that is resistant to or has progressed following an oxaliplatin-containing regimen. It is the same drug as aflibercept, which was approved last year as an intravitreal injection (Eylea) for treatment of neovascular (wet) agerelated macular degeneration (AMD). Ziv-aflibercept is the second VEGF inhibitor approved for treatment...

The FDA has approved an inhalation powder formulation of loxapine (Adasuve – Teva), a first-generation antipsychotic long available in an oral formulation, for treatment of acute agitation related to schizophrenia or bipolar I disorder in adults. Adasuve is the first inhaled drug to be approved for this indication.

The FDA has approved a sublingual powder formulation of nitroglycerin (GoNitro – Espero) for prevention or acute relief of an attack of angina pectoris. It is the first powder formulation of nitroglycerin to become available in the US. Most patients with angina use sublingual nitroglycerin tablets (Nitrostat, and generics). Translingual spray formulations of nitroglycerin (NitroMist, Nitrolingual Pumpspray, and generics) are also available.

Rilonacept (Arcalyst – Kiniksa), an interleukin-1 (IL-1) antagonist that has been available for years for treatment of cryopyrin-associated periodic syndromes, has now been approved by the FDA for treatment of recurrent pericarditis and prevention of further recurrences in patients ≥12 years old. It is the first drug to be approved in the US for this indication. Anakinra (Kineret), an IL-1 receptor antagonist FDA-approved for treatment of rheumatoid arthritis, has been used off-label for years for treatment of recurrent pericarditis.

Sotorasib (Lumakras — Amgen), an oral KRAS inhibitor, has received accelerated approval by the FDA for treatment of KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC) in adults who received at least one prior systemic therapy. Accelerated approval was based on the overall response rate and duration of response. KRAS mutations are found in 25-30% of non-squamous-cell NSCLC cases and the G12C mutation is the most common KRAS mutation. Sotorasib is the first KRAS inhibitor to be approved in the US.

The FDA has approved ensartinib (Ensacove – Xcovery), an oral kinase inhibitor, for treatment of anaplastic lymphoma kinase (ALK)-positive, locally advanced or metastatic non-small cell lung cancer (NSCLC) in adults who have not previously received an ALK inhibitor (e.g, crizotinib [Xalkori], certinib [Zykadia], alectinib [Alecensa], brigatinib [Alunbrig], lorlatinib [Lorbrena]). All previously approved ALK inhibitors are also approved for first-line use.

Losartan potassium (Cozaar - Merck), the first angiotensin II receptor antagonist, has been approved for oral treatment of hypertension by the US Food and Drug Administration. It will be marketed both alone and in a fixed-dose combination with the diuretic hydrochlorothiazide (Hyzaar).