Duetact (Takeda), a new fixed-dose combination of the thiazolidinedione pioglitazone (Actos) and the sulfonylurea glimepiride (Amaryl, and others), was recently approved by the FDA for treatment of type 2 diabetes. It is approved as an adjunct to diet and exercise to improve glycemic control in patients already taking pioglitazone and/or a sulfonylurea. Avandaryl, a combination of glimepiride and the thiazolidinedione rosiglitazone, was approved in 2006.

Flosequinan (Manoplax - Boots), a fluoroquinolone derivative, is now available in the USA for treatment of congestive heart failure. Labeling approved by the US Food and Drug Administration recommends the drug only for patients who cannot tolerate or have not responded adequately to an angiotensin-converting enzyme (ACE) inhibitor.

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.

Propafenone (Rythmol - Knoll), a class IC antiarrhythmic drug used in Europe for treatment of various arrhythmias for more than 10 years, was recently marketed in the USA for oral treatment of life-threatening ventricular arrhythmias such as sustained ventricular tachycardia. This restrictive labeling reflects concerns arising from the interim report of the Cardiac Arrhythmia Suppression Trial, in which post-myocardial infarction patients with asymptomatic or mildly symptomatic ventricular arrhythmias treated with the class IC antiarrhythmic drugs encainide (Enkaid) or flecainide...

The FDA has approved a once-daily extended-release (ER) formulation of the antiepileptic topiramate (Trokendi XR – Supernus) for initial monotherapy in patients ≥10 years old with partial onset seizures or primary generalized tonic-clonic seizures and for adjunctive therapy in patients ≥6 years old with partial onset seizures, primary generalized tonic-clonic seizures, or seizures associated with Lennox-Gastaut syndrome. Topiramate has been available for many years as an immediate-release (IR) formulation (Topamax, and generics) for the same indications in patients ≥2...

The FDA has approved valbenazine (Ingrezza – Neurocrine Biosciences), a vesicular monoamine transporter 2 (VMAT2) inhibitor, for treatment of tardive dyskinesia in adults. It is the first drug to be approved in the US for this indication; two other VMAT2 inhibitors, tetrabenazine (Xenazine, and generics) and deutetrabenazine (Austedo), were approved earlier for treatment of chorea associated with Huntington's disease.

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.

When used for the appropriate seizure type, antiseizure medications (ASMs) are roughly equivalent in efficacy. In addition to the seizure type, the choice of drug is usually based on factors such as ease of use, spectrum of activity, adverse effects, interactions with other drugs, presence of comorbid conditions, suitability for elderly persons and those with childbearing potential, and cost. Treatment should begin with a single drug, increasing the dosage gradually until seizures are controlled or adverse effects become unacceptable. If seizures persist, expert clinicians generally...

Rivastigmine tartrate (Exelon - Novartis), a carbamate-based cholinesterase inhibitor, is now being marketed for treatment of patients with dementia due to Alzheimer's disease.

The FDA has approved acoramidis (Attruby – BridgeBio), an oral transthyretin stabilizer, to reduce cardiovascular-related hospitalization and cardiovascular death in adults with wild-type or variant (hereditary) transthyretin amyloid cardiomyopathy (ATTR-CM). Acoramidis is the second transthyretin stabilizer to be approved in the US for this indication; tafamidis (Vyndaqel, Vyndamax) was approved in 2019.