fbpx
March 19, 2024

FDA Roundup: March 19, 2024

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 […]
March 19, 2024

Novel Drug Approvals for 2015

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 […]
March 19, 2024

Novel Drug Approvals for 2016

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 […]
March 19, 2024

Novel Drug Approvals for 2017

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 […]
March 19, 2024

Search for Pharmaceutical Quality Documents

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, […]
March 18, 2024

Novel Drug Approvals for 2018

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 […]
google.com, pub-5711488453051849, DIRECT, f08c47fec0942fa0