For Immediate Release: March 19, 2024 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:  Today, the […]

No. DrugName Active Ingredient Date FDA-approved use on approval date* 45. Zurampic lesinurad 12/22/2015 To treat high blood uric acid levels associated with goutDrug Trials Snapshot […]

On This Page Date: April 25, 2024 Time: 1:00 PM – 4:00 PM ET AGENDA Visit CDER Small Business and Industry Assistance Page ABOUT THIS EVENT […]

Helping Guide the Way for New Medicines Innovation drives progress. When it comes to innovation in the development of new drugs and therapeutic biological products, FDA’s […]

On March 19, 2024, the Food and Drug Administration granted accelerated approval to ponatinib (Iclusig, Takeda Pharmaceuticals U.S.A., Inc.) with chemotherapy for adult patients with newly […]

Helping Guide the Way for New Medicines Innovation drives progress. When it comes to innovation in the development of new drugs and therapeutic biological products, FDA’s […]

Product: Drugs Recipient: Recipient Name Steve Welch Recipient Title Owner Skull Smash LLC 3101 Bartold AvenueMaplewood, MO 63143-3600United States [email protected] Issuing Office: Center for Drug Evaluation […]

Reformulating Drug Products That Contain Carbomers Manufactured With Benzene Guidance 12/28/2023 NDA (new drugs), ANDA (generic drugs), DMF (drug master files), Drug Product, CGMP, Compendial Standards, […]

No. DrugName Active Ingredient Approval Date FDA-approved use on approval date* 59. Ultomiris ravulizumab 12/21/2018 To treat paroxysmal nocturnal hemoglobinuria (PNH)Press ReleaseDrug Trials Snapshot 58. Elzonris […]