The FDA has approved Vybrique (IBSA), an oral film formulation of the phosphodiesterase type 5 (PDE5) inhibitor sildenafil, for treatment of erectile dysfunction (ED). Sildenafil oral tablets (Viagra, and generics) have been available since 1998. The manufacturer is promoting the new product as a "discreet, on-the-go" option that can be taken without water.

The FDA has approved Nuedexta (Avanir), a fixed-dose combination of the cough suppressant dextromethorphan hydrobromide and the antiarrhythmic quinidine sulfate, for oral treatment of pseudobulbar affect. The combination is the first treatment approved by the FDA for this indication. Studies to support the effectiveness of Nuedexta were performed in patients with underlying amyotrophic lateral sclerosis (ALS) or multiple sclerosis (MS); the drug has not been shown to be safe or effective in other types of emotional lability.

An unpublished 2-year randomized study (ENHANCE) on the effect of adding ezetimibe 10 mg to simvastatin 80 mg in 720 patients with heterozygous familial hypercholesterolemia has been in the news recently. About 80% of these patients had previously been treated with statins. The primary endpoint was the change in the intima-media thickness (IMT) of the carotid artery (baseline 0.68 and 0.69 mm); the IMT increased by 0.0111 mm with ezetimibe plus simvastatin and 0.0058 mm with simvastatin 80 mg alone (p=0.29). The ezetimibe- simvastatin combination lowered LDL-C by 58% compared to 41% lowering...

Dordaviprone (Modeyso – Jazz), an oral protease activator, has received accelerated approval from the FDA for treatment of diffuse midline gliomas harboring a H3 K27M mutation in patients ≥ year old who had disease progression following prior treatment. It is the first drug to be approved in the US for this indication.

The FDA has approved Inqovi (Taiho Oncology), a fixed-dose combination of the nucleoside metabolic inhibitor decitabine and the cytidine deaminase inhibitor cedazuridine, for use in combination with venetoclax (Venclexta, and generics) for oral treatment of newly diagnosed acute myeloid leukemia (AML) in adults who are ≥75 years old or who have comorbidities that prevent use of intensive induction chemotherapy. The combination was approved in 2020 for treatment of myelodysplastic syndromes (MDS). IV decitabine or azacitidine plus oral venetoclax has been used for treatment of newly...

Donepezil hydrochloride (Aricept - Eisai), a piperidine-based acetylcholinesterase inhibitor, is now being marketed for oral treatment of cognitive symptoms in patients with mild to moderate dementia due to Alzheimer's disease. Donepezil is the second drug approved for this indication; tacrine hydrochloride (Cognex), also an acetylcholinesterase inhibitor, has been available in the USA for four years (Medical Letter, 35:87, 1993).

Vimseltinib (Romvimza – Deciphera), an oral kinase inhibitor, has been approved by the FDA for treatment of symptomatic tenosynovial giant cell tumor in adults for whom surgical resection would cause worsening functional limitation or severe morbidity. The kinase inhibitor pexidartinib (Turalio) was approved for a similar indication in 2019.

Sitagliptin (Januvia) and metformin (Glucophage, and others) are now available in a single tablet (Janumet - Merck) for treatment of type 2 diabetes. The combination is approved by the FDA for use in patients not adequately controlled by sitagliptin or meformin alone or in those already taking both drugs. Metformin is also available in combination with the thiazolidinediones pioglitazone and rosiglitazone and with the sulfonylureas glipizide and glyburide.

Levocetirizine (Xyzal - UCB/Sanofi-aventis), the active enantiomer of the second-generation H₁-antihistamine cetirizine (Zyrtec), has been approved by the FDA for treatment of seasonal and perennial allergic rhinitis (SAR and PAR) and chronic idiopathic urticaria in adults and children 6 years of age and older. Cetirizine has been approved by the FDA for over-the-counter use and may also become available generically in the US. Levocetirizine has been available in Europe since 2001.

Trospium chloride (Sanctura - Indevus/Odyssey) has been approved by the FDA for treatment of overactive bladder with symptoms of urge urinary incontinence, urgency and urinary frequency. It has been available in Europe for many years.