Olanzapine (Zyprexa - Lilly), a thienobenzodiazepine that structurally resembles and binds to many of the same receptors as clozapine (Clozaril), is now available in the USA for treatment of schizophrenia and other psychotic disorders.

The FDA has approved belinostat (Beleodaq – Spectrum), an IV histone deacetylase (HDAC) inhibitor, for treatment of adults with relapsed or refractory peripheral T-cell lymphoma (PTCL). It is the third IV drug approved by the FDA for PTCL. The first was the antifolate drug pralatrexate (Folotyn), which was followed by the HDAC inhibitor romidepsin (Istodax). Vorinostat (Zolinza), an oral HDAC inhibitor, is FDA-approved for treatment of cutaneous T-cell lymphoma.

The FDA has approved the use of a responsive neurostimulator device (RNS System – NeuroPace) for adjunctive treatment of adults with partial-onset seizures that are not controlled with ≥2 antiepileptic drugs and who have frequent and disabling seizures and no more than 2 epileptogenic foci.

Acamprosate calcium (Campral - Forest) is now being marketed for oral use to maintain abstinence from alcohol. It has been used in France and other countries since 1989.

Nabilone, an oral synthetic cannabinoid similar to delta-9-tetrahydrocannabinol (THC), the active ingredient in marijuana, has recently been reintroduced to the US market (Cesamet - Valeant) after a 17-year absence. The previous manufacturer discontinued marketing of the drug for commercial reasons. Nabilone is classified as a Schedule II controlled substance.

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 FDA has approved Glyxambi (Boehringer Ingelheim/Lilly), a fixed-dose combination of empagliflozin (Jardiance) and linagliptin (Tradjenta), for oral treatment of type 2 diabetes in adults. It is the first combination of a sodium-glucose co-transporter 2 (SGLT2) inhibitor and a dipeptidyl peptidase-4 (DPP-4) inhibitor to be approved in the US.

Butenafine hydrochloride 1% cream (Mentax - Penederm), a benzylamine antifungal drug similar to the allylamines terbinafine (Lamisil) and naftifine (Naftin), is now available in the USA for topical treatment of tinea pedis, tinea corporis and tinea cruris.

Clopidogrel bisulfate (Plavix - Bristol-Myers Squibb/Sanofi), a new thienopyridine antiplatelet agent similar to ticlopidine (Ticlid - Medical Letter, 34:65, 1992), has been approved by the US Food and Drug Administration (FDA) for secondary prevention of myocardial infarction, stroke and other vascular events.

The FDA has required a new warning in the label of the oral selective neurokinin 3 (NK3) receptor antagonist fezolinetant (Veozah) about the risk of hepatoxicity. The label of fezolinetant, which was approved by the FDA in 2023 for treatment of moderate to severe vasomotor symptoms due to menopause, already contained a warning about hepatic transaminase elevations associated with use of the drug.