Office of Inspector General isues demand letter to PharMerica Drug Systems based on alleged kickback violations, damages total $21.8 million
FDA Approves Nitisinone for Treatment of Alkaptonuria
Alkaptonuria affects approximately 1 in 250,000 to 1 million people in the United States.
Episode 8: Stay in Sync with Innovations in Medication Decision Support
Episode 8 of Over the Counter discusses the new and exciting modernizations in the medication decision support space.
FDA Approves Acoltremon Ophthalmic Solution for Dry Eye Disease
The new approval is for a first-in-class TRPM8 receptor agonist to stimulate corneal sensory nerves to increase natural tear production.
FDA Approves Hydrocortisone Oral Solution for Adrenocortical Insufficiency
The replacement therapy is indicated for patients 5 years and older, marking the first approval for an oral solution form of hydrocortisone.
FDA Grants Interchangeability Designation to Adalimumab-Bwwd for Humira
This designation follows Hadlima’s low-concentration prefilled syringes and single-dose vials, which were designated in June 2024.
FDA Approves Ustekinumab-Hmny as Biosimilar to Stelara
Ustekinumab is a medication used to treat and manage inflammatory conditions, including psoriasis, psoriatic arthritis, and inflammatory bowel disease.