FDA Actions in Brief as reported January 1, 2002
UnitedHealthcare Adds Deductibles to Medicare Part D for 2025
UnitedHealthcare is adding deductibles to Part D prescriptions on certain formulary tiers as a result of plan design changes from the Inflation Reduction Act.
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NDA Resubmitted for Dry Eye Treatment Reproxalap
Dry eye disease affects up to 15% of the U.S. population and is one of the largest markets in the ophthalmology field.
Stelara Biosimilar Otulfi Approved by FDA to Treat Multiple Autoimmune Disorders
Otulfi is the fourth Stelara biosimilar to be approved by the FDA.
Blue Shield of California to Offer Humira Biosimilar Idacio
Blue Shield of California is purchasing Idacio for a net price of $525 per monthly dose, and most plan members will pay $0 out of pocket.
FDA Approves Dupixent for Patients with COPD
This is the sixth indication for Dupixent and the only biologic approved in the United States to treat COPD.
FDA Approves the Oral Medication KarXT for Schizophrenia
KarXT — now with the brand name Cobenfy— is expected to be available in October with a list price of about $22,500 annually. The drug represents a new way to treat adults with schizophrenia.
