The FDA has approved the marketing of another extended-release brand-name formulation of the serotonin and norepinephrine reuptake inhibitor (SNRI) desvenlafaxine (Khedezla – Par/Osmotica) for treatment of depression. It is the third extended-release formulation of desvenlafaxine to become available in the US. Khedezla was approved using a 505(b)(2) application, a new drug application (NDA) that relies upon the FDA's findings of safety and/or effectiveness for a previously approved drug.Khedezla does not appear to offer any advantage over the other extended-release formulations of...

The FDA has approved an extended-release fixed-dose combination of dextromethorphan and bupropion (Auvelity – Axsome) for treatment of major depressive disorder (MDD) in adults.

The FDA has approved the GABA_A receptor modulator brexanolone (Zulresso – Sage Therapeutics) for IV treatment of postpartum depression (PPD). Brexanolone is the first drug to be approved by the FDA for this indication.

Older patients are especially susceptible to drug-induced cognitive impairment. They are more likely to be taking multiple drugs, to have higher blood levels of those drugs because of renal or hepatic dysfunction, and to have pre-existing cognitive problems that make it difficult to detect the role of drugs causing new symptoms or making old ones worse.

Augmentation with a second-generation (atypical) antipsychotic is a treatment option for patients with major depressive disorder (MDD) whose symptoms persist following antidepressant monotherapy. Aripiprazole (Abilify), olanzapine in a fixed-dose combination with fluoxetine (Symbyax), and extended-release quetiapine (Seroquel XR) have been approved by the FDA for such use.

Recent reports have suggested that some obese patients may benefit from long-term pharmacologic treatment (RL Atkinson and VS Hubbard, Am J Clin Nutr, 60:153, August 1994; DJ Goldstein and JH Potvin, Am J Clin Nutr, 60:647, November 1994). Fluoxetine (Prozac), widely used for treatment of depression and near approval by the US Food and Drug Administration (FDA) for treatment of bulimia, is also being tried for treatment of obesity.

The oral second-generation antipsychotic drug lumateperone (Caplyta – Intra-Cellular Therapies), which was approved by the FDA in 2020 for treatment of schizophrenia, is now approved for use as monotherapy or as an adjunct to lithium or valproate for treatment of depressive episodes associated with bipolar I or II disorder in adults.

Fezolinetant (Veozah – Astellas), a first-in-class neurokinin 3 (NK3) receptor antagonist, has been approved by the FDA for treatment of moderate to severe vasomotor symptoms (VMS) due to menopause. It is the second nonhormonal treatment to be approved in the US for this indication; a low-dose formulation of the selective serotonin reuptake inhibitor (SSRI) paroxetine mesylate (Brisdelle) was approved in 2013.

The FDA has asked the manufacturers of the selective serotonin reuptake inhibitor (SSRI) antidepressant citalopram (Celexa, and others) to revise the labeling of the drug to include new warnings about the risk of QT interval prolongation.

The FDA recently approved the monoamine oxidase inhibitor (MAOI) selegiline in a transdermal (patch) formulation (Emsam - Bristol-Myers Squibb/Somerset) for treatment of major depressive disorder. Selegiline is also available in an oral formulation (Eldepryl, and others) for treatment of Parkinson's disease.