Formulary Watch |

Sandoz Recalls One Lot of Enoxaparin

A temperature change during shipping could impact the product’s effectiveness. Enoxaparin is used to prevent deep vein thrombosis.

BMS Updates Safety Label for Inrebic

FDA Accepts for Priority Review Supplemental Application of Reblozyl

The FDA is reviewing Reblozy to treat anemia in patients with beta thalassemia. The PDUFA action date is March 27, 2022.

Pharmacy Organizations Criticize CMS COVID-19 Decision

FDA Approves Vaccine for Hepatitis B

PreHevBrio is a three-antigen hepatitis B vaccine for adults in the United States. It is expected to be available in the first quarter of 2022.

Merck Submits Application for Vaxneuvance for Children, Adolescents

The FDA has set a PDUFA action date of April 1, 2022.

ICER: Fair Access to Prescription Drugs Varies Across Payers

FDA Accepts BMS Application for Psoriasis Therapy

The FDA has assigned a Prescription Drug User Fee Act goal date of Sept. 10, 2022, for deucravacitinib. If approved, it would be the first TYK2 inhibitor approved for the treatment of any disease.

Advisory Committee Recommends Authorization of the COVID-19 Anti-viral Molnupiravir

If the FDA authorizes molnupiravir, it would be the first oral anti-viral to treat COVID-19 that patients can take at home.

Study: Hospitals Charge Insurers, Cash Patients More for Drugs

The FDA Grants Priority Review for Lynparza for Early Breast Cancer

FDA Approves Imaging Agent to Detect Ovarian Cancer

Cytalux is the first imagining agent to illuminate ovarian cancer during surgery.

Study Finds Patients with Hypertension Take Drugs that Raise Blood Pressure

Merck Releases Updated Data on its COVID-19 Antiviral

Merck now says molnupiravir reduces the risk of hospitalization or death from COVID-19 by 30% after all data have been analyzed. Previously, an interim analysis showed a 50% reduction in hospitalization or death.

New COVID-19 Variant is Identified

Study: Generic Statins Led to Significant Cost Savings

FDA Pauses Clozapine REMS Program

Walgreens Offering Biosimilar and Interchangeable Insulin Semglee

FDA Approves Treatment for Post-Transplant Infection

Livtencity is the first therapy approved to treat cytomegalovirus infection, which is common after transplants.

Large Study Finds Aduhelm Can be Associated with Brain Swelling

OptumRx Excludes the Diabetes Biosimilar Semglee from Formulary

Recent Generic Launches

Several new generics have launched in the United States, including for the migraine therapy Zomig, the anticancer therapy Doxil, and an anti-inflammatory used to treat respiratory conditions associated with COVID-19.

FDA Accepts for Priority Review Gene Therapy for Rare Blood Disorder

If approved, Bluebird Bio’s beti-cel would be the first one-therapy for β-thalassemia. The PDUFA date is May 20, 2022.

Long-term Study Shows Pfizer COVID-19 Vaccine is 100% Effective in Adolescents

Pfizer/BioNTech plan to use this data to support submissions for full approval of the vaccine in those 12 to 15 years old.

Sagent Recalls Four Lots of Levetiracetam

The antiseizure medication affected by the recall could have sterility issues.

Formulary Watch Drug Shortage Update — November 21, 2021

Gilead Submits BLA for Chronic Hepatitis Therapy

Bulevirtide has been granted breakthrough therapy and orphan drug designations by the FDA.

FDA Approves First Drug for a Form of Dwarfism

BioMarin’s Voxzogo is expected to be available in the United States by mid- to late-December.

FDA Expands EUA for Moderna and Pfizer COVID-19 Boosters

The boosters are now authorized for all people 18 years of age and older.

FDA Extends Review of Mavacamten to April 2022