On November 28, 2018, the Food and Drug Administration approved gilteritinib (XOSPATA, Astellas Pharma US Inc.) for treatment of adult patients who have relapsed or refractory […]

Summary Company Announcement Date: July 29, 2023 FDA Publish Date: July 31, 2023 Product Type: Drugs Reason for Announcement: Recall Reason Description Out of Specification Results […]

Summary Company Announcement Date: September 23, 2019 FDA Publish Date: September 23, 2019 Product Type: Drugs Reason for Announcement: Recall Reason Description Due to an Elevated […]

Summary Company Announcement Date: May 11, 2021 FDA Publish Date: May 11, 2021 Product Type: Drugs Reason for Announcement: Recall Reason Description Undeclared Tadalafil and Sildenafil […]

Summary Company Announcement Date: September 03, 2021 FDA Publish Date: September 07, 2021 Product Type: Drugs Reason for Announcement: Recall Reason Description Presence of visible particulate […]

Albuterol inhalers that contain chlorofluorocarbons (CFCs) will not be sold in the U.S. after December 31, 2008. Albuterol inhalers that contain hydrofluoroalkanes (HFAs) will take the […]

For Immediate Release: July 28, 2023 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:  On Thursday, […]

On This Page Date: September 28, 2023 Time: 8:45 AM – 4:45 PM ET Agenda Visit CDER Small Business and Industry Assistance Page ABOUT THIS EVENT […]

For Immediate Release: July 28, 2023 Today, the U.S. Food and Drug Administration approved RiVive, 3 milligram (mg) naloxone hydrochloride nasal spray for over-the-counter (OTC), nonprescription […]