FDA approvals and clearances

What it is

The FDA publishes its decisions on drugs and medical devices through openFDA. We list approved drug applications and the changes approved to them, 510(k) clearances of devices and premarket approvals (PMA) of higher-risk devices, and match the applicant to a public company when the name lines up. The page opens on new brand-name drugs and biologics: the first approval of a new drug application (NDA) or biologics license application (BLA).

Who files it

The FDA decides; openFDA publishes the FDA's records. The applicant is the company named in the FDA's record for the application.

How current

We check openFDA every day. The FDA refreshes its files on its own schedule, and a decision can appear days to weeks after its date, so the latest approvals may show up late.

Terms

openFDAopenFDA is the FDA's public data service. It publishes the FDA's own records of drug approvals and device decisions. openFDA asks users not to imply that the FDA endorses their product or service: this site is not endorsed by or affiliated with the FDA.NDA and BLAA new drug application (NDA) asks the FDA to approve a drug made from chemicals. A biologics license application (BLA) asks for a biologic, such as an antibody or a vaccine. The first approval is the original.supplementA later approved change to a drug that is already on the market: a new use, a new dose, a label change or a manufacturing change. Many supplements are minor.generic drugsA generic drug (an ANDA, or abbreviated new drug application) is approved because it matches a drug already on the market. Generics are made by many companies, most of which are not public.510(k)A device maker shows the FDA that its device is substantially equivalent to one already sold. The FDA clears it, which is a lighter review than an approval.PMAPremarket approval: the FDA's strictest review, for higher-risk devices. The maker must show the device is safe and effective.company matchWe match the applicant's name to a public company automatically, and by hand for the large drugmakers. Most applicants, such as generic makers and private device makers, do not match, and a subsidiary or a differently spelled name can be missed.

Worth knowing

This is a record of decisions already made. It is not a calendar of coming decisions: a drug under review does not appear, and we show no review dates. openFDA asks users not to imply that the FDA endorses their product or service: this page is not endorsed by or affiliated with the FDA, and the FDA makes no warranty about the data. It is not for medical decisions. Most applicants, such as generic makers and private device makers, do not match a public company, and a subsidiary or a differently spelled name can be missed, so a row with no ticker may still belong to one. A clearance is not an approval, and many approved supplements are minor.

Not to be confused with

Clinical trial updates: what sponsors report about their studies, not what the FDA decided.

All of this comes from openFDA, the FDA's public data service. This site is not endorsed by or affiliated with the FDA.