The FDA has approved the atypical antipsychotic pimavanserin (Nuplazid – Acadia) for treatment of hallucinations and delusions associated with Parkinson's disease. It is the first drug to be approved in the US for this indication.

The sodium-glucose cotransporter 2 (SGLT2) inhibitor dapagliflozin (Farxiga), which was initially approved by the FDA for treatment of type 2 diabetes and then to reduce the risk of hospitalization for HF in adults who have type 2 diabetes and established cardiovascular disease (CVD) or multiple cardiovascular risk factors, has now been approved for a third indication: to reduce the risk of cardiovascular death and hospitalization for heart failure (HF) in patients with heart failure with reduced ejection fraction (with or without type 2 diabetes). It is the first SGLT2 inhibitor to...

The FDA has issued an Emergency Use Authorization (EUA) for a lower-strength (10 mcg/0.2 mL) formulation of the mRNA-based COVID-19 vaccine manufactured by Pfizer/BioNTech (Comirnaty) for use in children 5-11 years old. The original formulation of (Comirnaty) (30 mcg/0.3 mL) is FDA-licensed for use in persons ≥16 years old and available under an EUA for use in adolescents 12-15 years old.

Etranacogene dezaparvovec-drlb (Hemgenix – CSL Behring), an adeno-associated virus vector-based gene therapy, has been approved by the FDA for treatment of hemophilia B in adults who currently receive factor IX prophylaxis therapy or have had life-threatening or repeated, serious, spontaneous bleeding episodes. It is the first gene therapy to be approved in the US for this indication.

The oral poly(ADP-ribose) polymerase (PARP) inhibitor talazoparib (Talzenna – Pfizer) has been approved by the FDA for use in combination with the androgen receptor blocker enzalutamide (Xtandi) for treatment of adults with homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer (mCRPC). The drug has been available since 2018 for treatment of deleterious or suspected deleterious germline BRCA-mutated (gBRCAm), HER2-negative locally advanced or metastatic breast cancer.

Tegaserod maleate (teg a ser' od; Zelnorm - Novartis), a serotonin derivative, has received FDA approval for short-term treatment of women with irritable bowel syndrome (IBS) whose primary symptom is constipation. Alosetron (Lotronex), which was withdrawn previously because of toxicity, will soon be available again for women with severe diarrhea-predominant IBS (Medical Letter 2002; 44:67).

Augmentin XR (GlaxoSmithKline), an oral extended-release combination of amoxicillin and the beta-lactamase inhibitor clavulanic acid, is now being promoted for treatment of acute bacterial sinusitis and community-acquired pneumonia. Augmentin XR contains a higher dose of amoxicillin than Augmentin.

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 steroid prasterone (Intrarosa – Endoceutics) for intravaginal treatment of postmenopausal women with moderate-to-severe dyspareunia due to vulvovaginal atrophy (VVA). Also called dehydroepiandrosterone (DHEA), prasterone is produced in the adrenal glands, gonads, and brain and converted intracellularly into active metabolites of estrogens and androgens. DHEA has been available over the counter for years as an oral dietary supplement claimed to benefit sexual, cardiovascular, and neuropsychiatric dysfunction.

Fitusiran (Qfitlia – Sanofi), a subcutaneously injected, antithrombin-directed, small interfering ribonucleic acid (siRNA), has been approved by the FDA for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in patients ≥12 years old who have hemophilia A with or without factor VIII inhibitors or hemophilia B with or without factor IX inhibitors. It is the first antithrombin-lowering therapy to become available in the US for treatment of hemophilia.