Formulary Watch |

Authorities Seize Fake Drugs with Lethal Doses of Meth and Fentanyl

Updated: FDA Approves $3.5 million Gene Therapy Hemgenix for Hemophilia B

FDA Warns About Prolia in Patients with Kidney Disease

An FDA review has found that Prolia can result in low calcium levels in the blood in patients with advanced kidney disease and can lead to hospitalization and death.

GSK Pulls Blenrep from U.S. Market

A confirmatory trial in patients with relapsed or refractory multiple myeloma did not meet its primary endpoint of progression-free survival.

Compounding Pharmacies to Help Alleviate Amoxicillin Shortage

FDA Accepts for Priority Review BLA for Epcoritamab

If approved, epcoritamab would be the first bispecific antibody to treat adult patients with relapsed/refractory large B-cell lymphoma. The Prescription Drug User Fee Act date is May 21, 2023.

FDA Updates Target Date for Pegcetacoplan

Appellis had submitted updated data for the pegcetacoplan in age-related macular degeneration, which is considered a major amendment to the NDA. The new PDUFA date is Feb. 26, 2023.

FDA Approves Alternate Dosing Schedule for Rylaze

Rylaze’s dosing options provide sustained asparaginase activity throughout the entire course of treatment for adult and pediatric patients with acute lymphoblastic leukemia or lymphoblastic lymphoma.

FDA Approves Second Interchangeable Lantus Biosimilar

Lilly’s Rezvoglar is a long-acting human insulin analog. It follows Semglee as a biosimilar that can be substituted for Lantus for both adults and children with diabetes.

FDA Approves First Drug that Delays Diabetes

OptumRx to Cover Amgen’s Biosimilar of Humira

Express Scripts Adds Zoryve to National Formulary

Launched in August, Zoryve is a once-daily, steroid-free cream and is the first topical PDE4 inhibitor approved to treat plaque psoriasis in patients 12 years of age or older.

FDA Advisory Committee Supports Xphozah in CKD

Generic Drug Roundup

Sun Pharma will market SPARC’s phenobarbital, which is under FDA review to treat neonatal seizures. In addition, several new generics have been approved, including a generic of Novartis’ Gilenya for multiple sclerosis and AbbVie’s Lupron for prostate cancer.

FDA Proposes Prescription-to-OTC Naloxone

GSK Limits Use of Zejula for Some Cancer Patients

OptumRx Makes Utilization Management Changes for 2023

FDA Grants Accelerated Approval of Novel Ovarian Cancer Therapy

Elahere is a first-in-class antibody-drug conjugate targeted against folate receptor alpha, a protein on the surface of ovarian cancer cells.

Omnipod 5 Charging Ports are Subject to Overheating

This is second issue related to Omnipod. Last week, the company announced that it had received 50 complaints related to the batteries of Omnipod DASH Personal Diabetes Manager.

FDA Approves Liletta IUD to Prevent Pregnancy for 8 Years

The approval extends the use of Liletta for an additional two years. It is the only hormonal IUD approved for continuous use up to eight years.

FDA Accepts NDA for Generalized Myasthenia Gravis Therapy

Zilucoplan is a targeted therapy that inhibits key components in the underlying disease pathology. The anticipated PDUFA date is in the fourth quarter of 2023.

Protalix, Chiesi Resubmit BLA to Treat Fabry Disease

PRX-102 is an enzyme replacement therapy for Fabry disease, a rare genetic disorder.

FDA Clears Imfinzi/Imjudo Combination for Lung Cancer

Imjudo is a monoclonal antibody that targets the activity CTLA-4 that was approved to be used in combination with Imfinzi, a PD-L1 inhibitor, for patients with non-small cell lung cancer.

FDA Accepts NDA for Novel Parkinson’s Disease Therapy

IPX203 is an oral formulation of carbidopa/levodopa extended-release capsules that, if approved, could provide patients with better symptom control. The FDA assigned a Prescription Drug User Fee Act date of June 30, 2023.

FDA Approves Adcetris for Younger Patients with Hodgkin Lymphoma

In a trial of patients two years and older, Adcetris plus standard of care chemotherapy led to a 59% reduction in risk of disease progression or relapse, second malignancy or death

How Long Should a PBM Implementation Take?

Hospital Demand for Amoxicillin Increases While Shortage Continues

FDA Accepts NDA of Aphexda for Use in Stem Cell Mobilization

If approved, Aphexdra would be used along with G-CSF treatment for autologous transplantation in patients with multiple myeloma. The Prescription Drug User Fee Act target action date is Sept. 9, 2023.

FDA Issues EUA for Kineret for Hospitalized COVID-19 Patients

Kineret has been granted an EUA for hospitalized adults with pneumonia who require supplemental oxygen.

Transcarent and Prescryptive Health Partner for Integrated Pharmacy