The FDA has approved lumateperone (Caplyta — Intracellular Therapies), an oral second-generation antipsychotic, for once-daily treatment of schizophrenia in adults. It is the 13th second-generation antipsychotic drug to be approved by the FDA for this indication.

The FDA has approved Phexxi (Evofem), a nonhormonal prescription-only vaginal gel containing lactic acid, citric acid, and potassium bitartrate, for prevention of pregnancy. The gel is intended for on-demand contraception; it is not effective when used after intercourse. It was previously approved for use as a vaginal lubricant (Amphora), but was never marketed.

The injectable glucagon-like peptide-1 (GLP-1) receptor agonist semaglutide, previously approved by the FDA as Ozempic to treat type 2 diabetes and to reduce the risk of major adverse cardiovascular events in adults with type 2 diabetes and established cardiovascular disease, has now been approved in a higher dose as Wegovy (Novo Nordisk) for chronic weight management in adults with or without type 2 diabetes who have a body mass index (BMI) ≥30 kg/m2 or a BMI ≥27 kg/m2 and ≥1 weight-related comorbidity (e.g., hypertension, dyslipidemia). An oral formulation of semaglutide...

The FDA has approved Winlevi (Sun), a 1% cream formulation of the androgen receptor inhibitor clascoterone, for treatment of acne vulgaris in patients ≥12 years old. It is the first topical androgen receptor inhibitor to be approved by the FDA.

Lisdexamfetamine dimesylate (Vyvanse - Shire), a prodrug in which d-amphetamine is covalently bonded to L-lysine, has been approved by the FDA for treatment of attention-deficit/hyperactivity disorder (ADHD) in children 6-12 years old. It was designed to have less potential than amphetamine itself for abuse, diversion or overdose toxicity. Like methylphenidate and amphetamines, lisdexamfetamine is a Schedule II controlled substance.

The FDA has approved delafloxacin (Baxdela – Melinta), an anionic fluoroquinolone antibiotic, for oral and parenteral treatment of adults with acute bacterial skin and skin structure infections (ABSSSIs), including those caused by methicillin-resistant Staphylococcus aureus (MRSA). It is the first fluoroquinolone to be approved for treatment of MRSA.

The FDA has approved the sodium-glucose co-transporter 2 (SGLT2) inhibitor ertugliflozin (Merck) for treatment of adults with type 2 diabetes, both alone (Steglatro) and in fixed-dose combinations with metformin (Segluromet) and sitagliptin (Steglujan). Ertugliflozin is the fourth SGLT2 inhibitor to be approved in the US. All four are available in combination with metformin and three are available in combination with a dipeptidyl peptidase-4 (DPP-4) inhibitor (see Table 3).

The FDA has approved omadacycline (Nuzyra – Paratek), a semisynthetic tetracycline derivative, for once-daily IV and oral treatment of community-acquired bacterial pneumonia (CAP) and acute bacterial skin and skin structure infections (ABSSSIs) in adults.

The FDA has approved Bijuva (TherapeuticsMD), a fixed-dose combination of estradiol and progesterone, for oral treatment of moderate to severe vasomotor symptoms (hot flashes) due to menopause in women with an intact uterus. The manufacturer is marketing Bijuva as "the first and only FDA-approved combination of bio-identical estradiol and bio-identical progesterone in a single daily oral capsule".

The FDA has approved IV amisulpride (Barhemsys – Acacia), a selective dopamine-2 and -3 (D₂/D₃) receptor antagonist, for prevention and treatment of postoperative nausea and vomiting (PONV) in adults. It is the first antiemetic to be approved for rescue treatment of PONV in patients who have symptoms despite receiving antiemetic prophylaxis. Oral formulations of amisulpride are available in Europe for treatment of schizophrenia and acute psychotic episodes.