Formulary Watch |

FDA Approves Biktarvy for Young Children with HIV

This low-dose formulation of Biktarvy is for younger children living with HIV.

FDA Issues Complete Response Letter to Omeros for Narsoplimab

Narsoplimab was under review at the FDA to treat a complication of stem cell transplants.

FDA Issues Complete Response Letter for Tyvaso DPI

The agency cited an open inspection issue at a facility that performs analytical testing of drug substance.

FDA Approves Tyrvaya for Dry Eye Disease

Tyrvaya is a twice daily nasal spray, a first for the treatment of dry eye disease.

Alkermes Launches the Antipsychotic Lybalvi

The FDA approved Lybalvi in June 2021 to treat schizophrenia and bipolar disorder.

FDA Approves First Interchangeable Biosimilar of Humira

Formulary Watch Drug Shortages Update — October 17, 2021

FDA Advisory Committee Recommends Approval of J&J COVID-19 Booster

The committee’s two-day meeting resulted in recommended approvals for both J&J’s and Moderna’s COVID-19 booster.

Otsuka, Lundbeck Submit sNDA for Rexulti in Adolescents with Schizophrenia

Submission is based on extrapolation analysis and results examining the effects of Rexulti in treating symptoms of schizophrenia in patients 13 to 17 years old. The FDA is expected to complete its review in December 2021.

PANTHERx Rare Pharmacy Selected to Distribute Tavneos

This is the second specialty pharmacy selected to distribute Tavneos, a first-in-class, oral therapy to treat a group of autoimmune diseases characterized by inflammation and damage to small blood vessels.

Regeneron Seeks Full Approval of COVID-19 Treatment

The FDA has assigned a target action date of April 13, 2022, and plans to hold an advisory committee meeting.

Advisory Committee Recommends Moderna COVID-19 Booster

The committee voted unanimously to support the booster given at least six months after the second dose in the original vaccine.

Lupin Recalls All Lots of Irbesartan Tablets and Irbesartan/Hydrochlorothiazide Tablets

FDA Approves Keytruda for Advanced Cervical Cancer

This is the first anti-PD-1 combination approved for patients with persistent, recurrent or metastatic cervical cancer.

FDA Allows Importation from Canada of Cefotaxime

Amber Specialty Chosen to Dispense Tavneos

FDA Clears Lilly’s Verenzio for Early Breast Cancer

FDA Approves First Therapy for Rare Immune Disorder

Rethmyic is a one-time regenerative tissue-based therapy for children born without a thymus gland.

Study: Share of Medicaid Spending on Drugs with Accelerated Approvals Increasing

Study Finds Libtayo is Cost-Effective Treatment for Cutaneous Squamous Cell Carcinomas

Corium Submits Application for Alzheimer’s Treatment in Patch Formulation

The company has received a PDUFA action date of March 11, 2022, for Adlarity, a transdermal patch for the treatment of Alzheimer’s disease.

Ocular Therapeutix Ophthalmic Inserts Gain Ocular Itching Indication

Inserts replace steroid eyedrops.

Genentech’s Alzheimer’s Drug Garners Breakthrough Therapy Designation

Merck Seeks EUA for COVID-19 Treatment

Molnupiravir reduced the risk of hospitalization or death by about 50%.

Drug Shortages Update — October 10, 2021

Pfizer Seeks EUA for COVID-19 Vaccine in Children

The announcement was made by Pfizer and BioNTech on Twitter

Janssen Submits Application for Stelara for Psoriatic Arthritis in Children

An FDA decision is expected in late 2022.

FDA Advisory Recommends Approval of Takeda’s Maribavir

If approved, maribavir would be the first therapy to treat transplant patients with cytomegalovirus.

Study: Financial Incentives Did Not Improve Cholesterol Levels in Those Taking Statins

Gavreto, Arcalyst Available Through AllianceRx Walgreens Prime