Stop distributing unapproved drugs included in kits On September 20, 2024, FDA requested Azurity Pharmaceuticals Inc. stop distributing unapproved drugs marketed as “Unit-of-Use Prescription Compounding Kits,” […]
Summary Company Announcement Date: October 22, 2019 FDA Publish Date: October 22, 2019 Product Type: Drugs Reason for Announcement: Recall Reason Description Contains Tadalafil Company Name: […]
HOW TO USE THIS SNAPSHOTThe information provided in Snapshots highlights who participated in the key clinical trials that supported the original FDA approval of this drug, […]
On September 25, 2024, the Food and Drug Administration approved osimertinib (Tagrisso, AstraZeneca Pharmaceuticals) for adult patients with locally advanced, unresectable (stage III) non-small cell lung […]
The current legislative authority for BsUFA, authorized in 2012 by the Food and Drug Administration Safety and Innovation Act (FDASIA) will expire in September 2017. The […]
Drug Sponsor Sponsor Medical Review Clinical Pharmacology Review Statistical Review BPCA or PREA or Both Abametapir – Xeglyze HATCHTECH PTY LTD Medical (PDF – 4 MB) Addendum (PDF […]
Pharmaceutical quality is the foundation that allows patients and consumers to have confidence in the safety and effectiveness of their medications. The Center for Drug Evaluation […]
FDA provides information to assist industry in the development of generic drugs and submission of abbreviated new drug applications (ANDAs). This section includes links to summary […]
Potential ANDA applicants are encouraged to contact the FDA Generic Drugs Program with questions at any point in their development and application preparation processes. If you […]
This website uses cookies to improve your experience. We'll assume you're ok with this, but you can opt-out if you wish. Cookie settingsACCEPTReject
Privacy & Cookies Policy
Privacy Overview
This website uses cookies to improve your experience while you navigate through the website. Out of these cookies, the cookies that are categorized as necessary are stored on your browser as they are essential for the working of basic functionalities of the website. We also use third-party cookies that help us analyze and understand how you use this website. These cookies will be stored in your browser only with your consent. You also have the option to opt-out of these cookies. But opting out of some of these cookies may have an effect on your browsing experience.
Necessary cookies are absolutely essential for the website to function properly. This category only includes cookies that ensures basic functionalities and security features of the website. These cookies do not store any personal information.
Any cookies that may not be particularly necessary for the website to function and is used specifically to collect user personal data via analytics, ads, other embedded contents are termed as non-necessary cookies. It is mandatory to procure user consent prior to running these cookies on your website.