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.
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A confirmatory trial in patients with relapsed or refractory multiple myeloma did not meet its primary endpoint of progression-free survival.
The FDA has issued a final guidance for beta-lactam oral antibiotic suspension products, including amoxicillin.
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.
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.
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.
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.
Tzield addresses the underlying cause of the disease, where the immune system destroys the insulin producing cells in the pancreas. It will be available by the end of the year with a wholesale acquisition cost of $13,850 per vial.
OptumRx will offer Amjevita and two other biosimilars alongside Humira. OptumRx is the first PBM to make public its plans for the seven Humira biosimilars that could be introduced in 2023.
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.
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If approved, Xphozah will be the first phosphate absorption inhibitor for adults with chronic kidney disease who are on dialysis. An FDA decision is expected within 30 days.
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.
The agency is encouraging sponsors to submit applications for low-dose, nonprescription naloxone products.
After review of phase 3 data, GSK will limit the use of Zejula in the second line to those with inherited BRCA mutations.
OptumRx now requires prior authorization for 16 products, including 11 that are used to treat patients with diabetes.
Elahere is a first-in-class antibody-drug conjugate targeted against folate receptor alpha, a protein on the surface of ovarian cancer cells.
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.
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.
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.
PRX-102 is an enzyme replacement therapy for Fabry disease, a rare genetic disorder.
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.
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.
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
A 10-day implementation has given the team at Abarca Health the opportunity to challenge how they manage implementations in general.
Vizient saw a 43% surge in demand for all amoxicillin products in the acute care setting from September to October, but fill rates have dropped 25%.
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.
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