The FDA has approved suvorexant (Belsomra – Merck), the first orexin receptor antagonist to become available in the US, for treatment of sleep-onset and/or sleep-maintenance insomnia.

The FDA has approved the oral Janus kinase (JAK) inhibitor upadacitinib (Rinvoq – Abbvie) for treatment of moderately to severely active ulcerative colitis in adults who have had an inadequate response to or cannot tolerate one or more tumor necrosis factor (TNF) inhibitors. Upadacitinib is the second JAK inhibitor to be approved for this indication; tofacitinib (Xeljanz) was the first. Upadacitinib is also approved for treatment of rheumatoid arthritis, psoriatic arthritis, atopic dermatitis, and ankylosing spondylitis.

The FDA has approved two new oral formulations of testosterone undecanoate — Kyzatrex (Marius) and Tlando (Antares) — for treatment of males with a deficiency of endogenous testosterone due to conditions such as Klinefelter syndrome, orchiectomy, toxic damage from chemotherapy or alcohol, or pituitary-hypothalamic injury caused by tumors, trauma, or radiation. Jatenzo, another oral testosterone undecanoate formulation, was approved for the same indication in 2019. No testosterone products are approved for treatment of low testosterone levels due solely to...

The FDA has approved an extended-release fixed-dose combination of dextromethorphan and bupropion (Auvelity – Axsome) for treatment of major depressive disorder (MDD) in adults.

Azelastine hydrochloride, a histamine-H1 receptor antagonist, has been marketed as a 0.1% nasal spray (Astelin - Wallace) for treatment of seasonal allergic rhinitis. Corticosteroid and cromolyn sodium nasal sprays are also available for this indication (Medical Letter, 37:5, 1995). Cromolyn sodium (Nasalcrom) has now been approved for over-the-counter use.

The FDA has approved the use of the 5α-reductase inhibitor dutasteride (Avodart - GlaxoSmithKline) together with the alpha₁-blocker tamsulosin (Flomax - Boehringer Ingelheim) for treatment of benign prostatic hyperplasia (BPH). Use of an alpha1-blocker with a 5α-reductase inhibitor has been a common practice for years, but FDA approval of a particular combination permits the manufacturers to add an indication for it in both package inserts, recommend dosage for combination use, and advertise the benefits of using the 2 drugs together.

The treatment of choice to prevent emesis due to highand moderate-risk emetogenic drugs used in cancer chemotherapy is aprepitant plus a serotonin receptor antagonist plus dexamethasone. Four serotonin receptor antagonists are available in the US in intravenous (IV) formulations for prevention of nausea and vomiting due to cancer chemotherapy, and 3 of these are also available for oral use. Now the FDA has approved one of these, granisetron, in a transdermal formulation (Sancuso - ProStrakan).

The FDA has approved flibanserin (Addyi – Sprout) for treatment of premenopausal women with acquired, generalized hypoactive sexual desire disorder (HSDD) not caused by another medical or psychiatric condition, the effects of another drug, or relationship difficulties. Flibanserin is the first drug to be approved for treatment of HSDD. It is not approved for use in men or postmenopausal women. Previous FDA reviews of flibanserin in 2010 and 2013 did not result in approval.

The FDA has approved Synjardy (Boehringer Ingelheim/Lilly), a fixed-dose combination of the sodium-glucose co-transporter 2 (SGLT2) inhibitor empagliflozin (Jardiance) and metformin (Glucophage, and others), for treatment of patients with type 2 diabetes not adequately controlled on either of these drugs alone or already being treated with both empagliflozin and metformin. It is the third SGLT2 inhibitor/metformin combination to be approved in the US.

The FDA has approved the opioid receptor antagonist naldemedine (Symproic – Shionogi) for treatment of opioid-induced constipation (OIC) in adults with chronic noncancer pain. Naldemedine is the third oral peripherally-acting mu-opioid receptor antagonist (PAMORA) to be approved for this indication; naloxegol (Movantik) and methylnaltrexone (Relistor) were approved earlier.