Vilazodone (Viibryd – Forest), a selective serotonin reuptake inhibitor (SSRI) and partial 5-HT_1A receptor agonist, has been approved by the FDA for treatment of depression. It has been claimed to have no sexual side effects and not to cause weight gain.

Brivaracetam (Briviact – UCB), an analog of levetiracetam (Keppra, and others), has been approved by the FDA for adjunctive treatment of partial-onset seizures in patients ≥16 years old. New drugs for epilepsy are often approved initially only as adjunctive treatment for partial seizures.

The FDA has approved the Obalon Balloon System (Obalon), a swallowable intragastric gas-filled balloon device, to facilitate weight loss in adults with a body mass index (BMI) of 30-40 kg/m² who have not been able to lose weight through diet and exercise. Two other gastric balloon devices, ReShape and Orbera, were approved earlier.

The FDA has approved darolutamide (Nubeqa – Bayer), an androgen receptor inhibitor, for oral treatment of nonmetastatic castration-resistant prostate cancer (nmCRPC). Darolutamide is the third androgen receptor inhibitor to be approved for this indication; apalutamide (Erleada) and enzalutamide (Xtandi), which are also approved for use in patients with metastatic castration-resistant prostate cancer (mCRPC), were approved earlier.

The FDA has approved the antiviral drug remdesivir (Veklury – Gilead) for IV treatment of COVID-19 in hospitalized patients who are ≥12 years old and weigh ≥40 kg. Hospitalized children who are <12 years old or weigh <40 kg can receive remdesivir through an Emergency Use Authorization (EUA). Remdesivir is the first drug to be approved in the US for treatment of COVID-19.

Fezolinetant (Veozah – Astellas), a first-in-class neurokinin 3 (NK3) receptor antagonist, has been approved by the FDA for treatment of moderate to severe vasomotor symptoms (VMS) due to menopause. It is the second nonhormonal treatment to be approved in the US for this indication; a low-dose formulation of the selective serotonin reuptake inhibitor (SSRI) paroxetine mesylate (Brisdelle) was approved in 2013.

The FDA recently expanded the eligibility criteria (see Table 1) for treatment with the surgically implanted hypoglossal nerve stimulation system (Inspire Upper Airway Stimulation – Inspire Medical Systems). The device has been advertised lately on radio and television.

The FDA has approved daxibotulinumtoxinA-lanm (Daxxify – Revance), an acetylcholine release inhibitor and neuromuscular blocking agent, for temporary improvement in the appearance of moderate to severe glabellar (frown) lines associated with corrugator and/or procerus muscle activity. Daxxify is the fifth botulinumtoxin type A product to be approved in the US for this indication (see Table 1). It is also approved for treatment of cervical dystonia in adults

The FDA has approved Exblifep (Allecra), a fixed-dose combination of the cephalosporin cefepime and the beta-lactamase inhibitor enmetazobactam, for IV treatment of adults with complicated urinary tract infections (cUTIs), including pyelonephritis, caused by designated susceptible microorganisms (see Spectrum of Activity). Exblifep is the first product that contains enmetazobactam to be approved in the US.

The FDA has approved a 12.45% gel formulation of the anticholinergic drug sofpironium (Sofdra – Botanix) for treatment of primary axillary hyperhidrosis (excessive underarm sweating) in patients ≥9 years old.