4/28/2023 NDA-019758 Clozaril (Clozapine) HERITAGE LIFE SCIENCES BARBADOS INC Archive 9/20/2021 NDA-018936 Prozac (Fluoxetine Hydrochloride) ELI LILLY AND COMPANY  Archive 4/11/2019 NDA-022526 Addyi (Flibanserin) SPROUT PHARMACEUTICALS […]

One this page Acetaminophen Improving prescription container labels for acetaminophen-containing medicines Acetaminophen, used for treating pain and fever, is one of the most common active ingredients […]

The risk of death from opioid use can be greatly increased when patients are taking other, non-opioid psychoactive therapeutics with sedative properties. To support safer labeling […]

En Español FDA is working with U.S. government partners including the Centers for Disease Control and Prevention (CDC), medical product manufacturers, and international partners to address […]

En Español Remove the Risk raises awareness of the serious dangers of keeping unused opioid pain medicines in the home and provides information about safe disposal […]

POCA System Overview The Phonetic and Orthographic Computer Analysis (POCA) program is a software tool that uses an advanced algorithm to determine the orthographic and phonetic […]

Thank you for joining us for another episode of the Guidance Recap Podcast. The Guidance Recap Podcast provides highlights for FDA guidance documents straight from the […]

Docket Number: FDA-2017-D-6821 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research Center for Biologics Evaluation and Research FDA is issuing this guidance to […]

Summary Company Announcement Date: July 18, 2024 FDA Publish Date: July 24, 2024 Product Type: Drugs Reason for Announcement: Recall Reason Description Device & Drug Safety […]