Formulary Watch Staff

First-in-class brensocatib has the potential to be the first approved treatment for bronchiectasis.

More than half of those who responded to a recent KFF survey say they are worried about paying for their prescription drugs.

June 7, 2024 is the target PDUFA date for the additional indication of GSK's respiratory syncytial virus vaccine Arexvy.

Regulators will continue to conduct additional evaluations to assess the link between GLP-1 drugs and suicidal thoughts or actions.

The perfluorohexyloctane ophthalmic solution from Bausch + Lomb was approved by the FDA in May and will have a whole acquisition cost of $771 for a one-month supply.

Quizartinib (Vanflyta) is an oral inhibitor of FLT3, and it specifically targets FLT3-ITD mutations, which drive cancer growth and contribute to increased risk of relapse and shorter overall survival.

Ycanth (cantharidin) was approved for the topical treatment of molluscum contagiosum in adult and pediatric patients 2 years of age and older as an in-office administered therapy.

Recent safety data also allowed four adverse events to be removed from the label.

The company will also add Sandoz’s unbranded version of adalimumab to its National Preferred Formulary.

The Humira biosimilar is a tumor necrosis factor (TNF) blocker and was approved by the FDA in 2021.

The revised guidance includes clarified aspects of the negotiation process and additional opportunities for engagement during the process.

Lodoco (colchicine) approval was based on a clinical trial with 5,522 patients with chronic coronary disease, which was published in Circulation in February 2022.

The new feature automatically applies manufacturer-sponsored coupons directly to an eligible patient’s order. So far, only a few pharma companies have made their coupons available through Amazon.

Regulatory officials said additional requirements are needed in order to approve the drug, which is under review for treatment of myelofibrosis, polycythemia vera, and graft-versus-host disease.

Evkeeza, which treats a rare form of high cholesterol, is now approved for patients as young of 5 years.

The spray, called Zavzpret, intends to help individuals who struggle with migraines but can't take oral medication because of nausea or vomiting

Voxzogo is already available for patients over 5 years with a genetic cause of dwarfism. The PDUFA date is set for Oct. 21, 2023, and will potentially expand the drug to children 5 and under.

Zuranolone, a fast-acting neuroactive steroid that can take effect in 14 days, has been assigned a PDUFA action date of Aug. 5, 2023 by the FDA. It can be used to treat patients with major depressive disorder and postpartum depression.

Elacestrant, now with the brand name Orserdu, is an oral selective estrogen receptor degrader (SERD), which works by blocking the effects of estrogen on hormone receptor-positive breast cancer cells.

There are no currently approved medications for the treatment of NASH.

Rykindo is a bi-weekly long-acting risperidone injection to treat patients with schizophrenia and bipolar 1 in adults.

Brexafemme is a non-azole oral antifungal now approved to both treat and prevent recurrent yeast infections in women.

The approval extends the use of Liletta for an additional 2 years.