Formulary Watch |

FDA Approves Orkambi for Expanded Use in Children with Cystic Fibrosis

With this approval, about 300 children between 12 months and 24 months will be eligible for treatment with Orkambi.

HHS Funds U.S. Monkeypox Vaccine Manufacturing

FDA Approves Novel Treatment for Rare Type of Psoriasis Flare

Spevigo is a monoclonal antibody that inhibits interleukin-36 (IL-36) signaling approved to treat for adults with generalized pustular psoriasis flares.

Amneal Submits NDA for Parkinson’s Disease Therapy

This application is for a new formulation of carbidopa/levodopa extended-release capsules to treat patients with Parkinson’s disease.

FDA Approves Xenpozyme for ASMD, a Rare Genetic Disorder

Xenpozyme, the first disease-specific treatment for acid sphingomyelinase deficiency (ASMD), is expected to be available in the United States in the coming weeks at a wholesale acquisition cost of $7,142 per vial.

Spending on Specialty Drugs Maintains Double-Digit Growth

Pharmacies Face Adderall Back Orders

Hikma Launches Ryaltris for Allergic Rhinitis

Ryaltris is a fixed-dose combination therapy that provides relief for both nasal and ocular symptoms of seasonal allergic rhinitis in a nasal spray.

FDA Authorizes Pfizer, Moderna Updated COVID-19 Boosters

The approval of the updated bivalent boosters is based on data from clinical studies of the omicron variant BA.1, and animal data on the omicron BA.4 and BA.5 variant.

Hospira Recalls Another Lot of Propofol

This recall of propofol because of particulates seen in vials follows a previous one in July 2022.

Updated: Mark Cuban CostPlus Lowers Prices of 30 Drugs

The direct-to-consumer pharmacy also added 13 new products, and now carries almost 1,000 medications.

FDA Grants Priority Review to Weekly Hemophilia A Therapy

The target action date for the agency’s decision for efanesoctocog alfa, a factor VIII therapy, is Feb. 28, 2023.

Survey: Consumers Worried about Prescription Drug Costs

AllianceRx Walgreens Pharmacy, Total Care Rx Chosen to Distribute to Hyftor

Hyftor was approved in April 2022 to treat patients with the rare disease facial angiofibroma associated with tuberous sclerosis complex.

Humira Biosimilars a Question Mark for Hospitals

FDA Approves First Targeted Treatment for Myeloid/Lymphoid Neoplasms

Pemazyre is the first approved treatment specifically for patients with FGFR1 rearrangement, a rare blood cancer.

FDA Expands Imbruvica for Young Children with GVHD

Imbruvica is the first approved treatment option for children under 12 with chronic graft versus host disease and the first BTKi therapy approved for pediatric patients.

CVS Caremark Provides Formulary Updates for October

Moderna Completes Application for Updated COVID-19 Booster

Pending authorization, Moderna will be ready to ship the updated bivalent booster in September 2022.

Study: Costs of Naloxone a Barrier for Uninsured Patients

FDA Accepts NDA for GSK’s Myelofibrosis Drug

FDA Expands Use of Omnipod 5 for Younger Children

Omnipod 5 is now available through retail pharmacies, as well as specialty and mail-order pharmacies.

Pfizer Submits EUA for Updated COVID-19 Booster

The updated COVID-19 vaccine booster specifically addresses the omicron BA.4/BA.5 variants. If authorized, it will be available to ship immediately.

FDA Grants EUA for Novavax COVID-19 Vaccine for Adolescents

Novavax’s vaccine is the first protein-based COVID-19 vaccine authorized in the United States.

FDA Approves Rapid-Acting Auvelity for Major Depression

Axsome anticipates Auvelity to be commercially available in the fourth quarter of 2022.

Akorn, Ani and Novadoz Launch New Generic Products

Recent approvals include a first generic for the infertility drug Cetrotide, as well as generics of Revatio, Velcade and Esbriet.

FDA Extends Mirena IUD for Eight Years of Use

Mirena, a long-acting hormonal IUD, was previously approved to prevent pregnancy for up to seven years.

Vizient Predicts Modest Drug Inflation in 2023

FDA to Review NDA for Nonhormonal Therapy for Menopause

If approved, fezolinetant would treat patients with moderate-to-severe hot flashes and/or night sweats associated with menopause. The PDUFA date is Feb 22, 2023.

Sanofi Stops Development of Amcenestrant