FDA Action Alert: Recent Developments on Unapproved Drugs and Prescription Drug Approvals
FDA Action on Unapproved Drugs:
The FDA requested Azurity Pharmaceuticals Inc. to stop distributing unapproved drugs marketed as "Unit-of-Use Prescription Compounding Kits," including FIRST Lansoprazole, FIRST Pantoprazole, FIRST Metronidazole, and FIRST Mouthwash BLM, due to lack of proven safety and effectiveness13.
Prescription Drug Approvals:
Bristol Myers Squibb announced an updated PDUFA goal date of December 29, 2024, for the subcutaneous formulation of Opdivo (nivolumab and hyaluronidase)2.
The FDA granted accelerated approval of Breyanzi, a CAR-T cell therapy for adults with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL)4.
Other FDA Actions:
The FDA has taken various actions against companies distributing unapproved drugs, including issuing warning letters and consent decrees of permanent injunction to several pharmaceutical companies3.
The FDA has also been updating its content to reflect organizational changes, including the reorganization impacting many parts of the agency as of October 1, 20245.
Sources:
1. https://www.fda.gov/drugs/enforcement-activities-fda/fda-notification-regarding-unapproved-drugs-included-kits
2. https://news.bms.com/news/details/2024/Bristol-Myers-Squibb-Announces-Updated-Action-Date-by-the-U.S.-Food-and-Drug-Administration-for-Subcutaneous-Nivolumab-nivolumab-and-hyaluronidase/default.aspx
3. https://www.fda.gov/drugs/enforcement-activities-fda/fda-actions-remove-unapproved-drugs-market-company
4. https://news.bms.com/news/details/2024/U.S.-FDA-Approves-Bristol-Myers-Squibbs-Breyanzi--as-the-First-and-Only-CAR-T-Cell-Therapy-for-Adults-with-Relapsed-or-Refractory-Chronic-Lymphocytic-Leukemia-CLL-or-Small-Lymphocytic-Lymphoma-SLL/default.aspx
5. https://www.fda.gov/drugs/warning-letters-and-notice-violation-letters-pharmaceutical-companies/untitled-letters