The FDA has approved a combination oral contraceptive containing the estrogen estetrol and the progestin drospirenone (Nextstellis – Mithra/Mayne). Estetrol is the first new estrogen to become available in the US in 50 years. Drospirenone is available alone (Slynd) and in combinations with the estrogen ethinyl estradiol for prevention of pregnancy.

Myfembree (Myovant/Pfizer), an oral fixed-dose combination of the gonadotropin-releasing hormone (GnRH) receptor antagonist relugolix, the estrogen estradiol, and the progestin norethindrone acetate, has been approved by the FDA for management of heavy menstrual bleeding associated with uterine leiomyomas (fibroids) in premenopausal women. It is the second product to be approved in the US for this indication; Oriahnn, which contains the GnRH receptor antagonist elagolix in combination with estradiol and norethindrone acetate, was approved earlier. Relugolix was approved for...

The FDA has approved Lybalvi (Alkermes), a fixed-dose combination of the second-generation antipsychotic olanzapine (Zyprexa, and generics) and samidorphan, a new opioid antagonist, for treatment of adults with schizophrenia or with manic or mixed episodes of bipolar I disorder. The addition of samidorphan is intended to mitigate the weight gain that occurs with olanzapine. This is the first FDA approval for samidorphan.

Oriahnn (Abbvie), a fixed-dose combination of the gonadotropin-releasing hormone (GnRH) receptor antagonist elagolix, the estrogen estradiol, and the progestin norethindrone acetate copackaged with elagolix alone, has been approved by the FDA for oral treatment of heavy menstrual bleeding associated with uterine leiomyomas (fibroids) in premenopausal women. It is the first product to be approved in the US for this indication. Elagolix (Orilissa) has been available since 2018 for treatment of moderate to severe pain associated with endometriosis. The GnRH receptor antagonist...

The FDA has approved ponesimod (Ponvory – Janssen), a sphingosine 1-phosphate (S1P) receptor modulator, for treatment of adults with relapsing forms of multiple sclerosis (MS), including clinically isolated syndrome (initial neurological episode), relapsing-remitting disease, and active secondary progressive MS (SPMS). Ponesimod is the fourth oral S1P receptor modulator to be approved in the US for once-daily treatment of relapsing forms of MS; ozanimod (Zeposia) and siponimod (Mayzent) are also approved for use in adults, and fingolimod (Gilenya) is indicated for use in patients...

The FDA has approved a sublingual film formulation of the alpha-2 adrenergic receptor agonist dexmedetomidine (Igalmi — BioXcel Therapeutics) for acute treatment of agitation associated with schizophrenia or bipolar I or II disorder in adults. It is the first alpha-2 agonist and the only sublingual film to be approved for this indication. Dexmedetomidine has been available for many years in an injectable formulation (Precedex) for sedation in the intensive care unit and to facilitate procedures such as mechanical ventilation.

The FDA has approved Combogesic IV (Hikma), an IV solution containing acetaminophen and ibuprofen, to treat mild to moderate pain (alone) or moderate to severe pain (in combination with an opioid) in adults when IV analgesia is considered clinically necessary. Single-drug IV solutions containing ibuprofen (Caldolor) and acetaminophen have been available in the US for years.

The FDA has approved the recombinant chimeric anti-CD20 antibody ublituximab-xiiy (Briumvi – TG Therapeutics) for IV treatment of adults with relapsing forms of multiple sclerosis (MS), including clinically isolated syndrome (initial neurological episode), relapsing-remitting disease, and active secondary progressive MS (SPMS). Two other anti-CD20 antibodies, IV ocrelizumab (Ocrevus) and SC ofatumumab (Kesimpta), are also FDA-approved for these indications.

The FDA has approved Trudhesa (Impel Neuropharma), a new dihydroergotamine nasal spray product, for acute treatment of migraine with or without aura in adults. Another dihydroergotamine nasal spray (Migranal, and generics) has been available for many years for the same indication.

Lonapegsomatropin-tcgd (Skytrofa – Ascendis), a long-acting prodrug of recombinant human growth hormone (rhGH), has been approved by the FDA for once-weekly subcutaneous (SC) treatment of growth failure due to inadequate secretion of endogenous growth hormone in children ≥1 year old who weigh ≥11.5 kg. It is the first once-weekly rhGH product to be approved in the US; other available rhGH formulations are administered more frequently.