The latest FDA action (through June 2007) related to sipuleucel-T (Provenge), tramadol (CIP-Tramadol ER), isotretinoin (CIP-Isotretinoin), bazedoxifene (Viviant), irbesartan plus hydrochlorothiazide (Avalide), prednisolone 1.0% plus tobramycin 0.3% ophthalmic suspension (T-Pred), pixantrone, SPRC-AB01
Approvable designations
Recommendation for approval
Nonapprovable designation
FDA Sets Date of Advisory Committee Meeting for Donanemab in Alzheimer’s Disease
May 7th 2024The Peripheral and Central Nervous System Drugs Advisory Committee will meet on Monday, June 10, 2024, to discuss the phase 3 trial of Lilly’s donanemab to treat patients with early symptomatic Alzheimer’s disease.