Amyvid

Used in scans for cognitive impairment. NDA 202008, held by Avid Radiopharms Inc. Florbetapir F-18.

As of Nov 13, 2026, NDA 202008 (Amyvid), held by Avid Radiopharms Inc, was first approved by FDA on Apr 6, 2012, with 25 approved supplements and 0 published complete response letters.

First approved: Apr 6, 2012
Review: Priority
Supplements approved: 25
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

AMYVID is indicated for positron emission tomography (PET) of the brain to estimate amyloid beta neuritic plaque density in adults with cognitive impairment for: Evaluation of Alzheimer's disease (AD) and other causes of cognitive decline Selection of patients who are indicated for amyloid beta-directed therapy as described in the prescribing information of the therapeutic products

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 26 submissions below

Date	Submission	Status	Documents
Jun 23, 2025	Supplement 46Efficacy (new indication or use) · Standard review	Approved	Label Letter
Apr 6, 2012	Original applicationNew molecular entity · Priority review	Approved	Review Label Letter

Products

4 strengths and forms

Product	Active ingredient	Marketing
Amyvid10ML (13.5-51mCi/ML) · solution;intravenous	Florbetapir F-18	DiscontinuedReference drug
Amyvid10-30ML (13.5-51mCi/ML) · solution;intravenous	Florbetapir F-18	DiscontinuedReference drug
Amyvid10-50ML (13.5-51mCi/ML) · solution;intravenous	Florbetapir F-18	RxReference drug
Amyvid10-100ML (13.5-51mCi/ML) · solution;intravenous	Florbetapir F-18	RxReference drug

All 26 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Jun 23, 2025	Supplement 46Efficacy (new indication or use) · Standard review	Approved	Label Letter
Oct 13, 2023	Supplement 44Manufacturing	Approved	Label Letter
Aug 19, 2022	Supplement 41Manufacturing	Approved	Letter
Dec 20, 2019	Supplement 36Labeling · Standard review	Approved	Letter Label
Jun 22, 2016	Supplement 26Manufacturing · Priority review	Approved	None posted
Mar 9, 2016	Supplement 25Manufacturing · Priority review	Approved	None posted
Jul 9, 2015	Supplement 22Manufacturing · Priority review	Approved	None posted
Jul 9, 2015	Supplement 24Manufacturing · Priority review	Approved	None posted
Jun 25, 2015	Supplement 23Manufacturing · Priority review	Approved	None posted
Mar 14, 2014	Supplement 21Manufacturing · Priority review	Approved	None posted
Dec 12, 2013	Supplement 20Labeling	Approved	Label Letter
Nov 8, 2013	Supplement 19Manufacturing · Priority review	Approved	None posted
Oct 25, 2013	Supplement 18Manufacturing · Priority review	Approved	None posted
Mar 27, 2013	Supplement 15Manufacturing · Priority review	Approved	None posted
Mar 22, 2013	Supplement 14Manufacturing · Priority review	Approved	None posted
Mar 22, 2013	Supplement 17Manufacturing · Priority review	Approved	None posted
Mar 13, 2013	Supplement 9Manufacturing · Priority review	Approved	None posted
Mar 6, 2013	Supplement 12Manufacturing · Priority review	Approved	None posted
Mar 6, 2013	Supplement 13Manufacturing · Priority review	Approved	None posted
Mar 6, 2013	Supplement 16Manufacturing · Priority review	Approved	None posted
Feb 19, 2013	Supplement 7Manufacturing · Priority review	Approved	None posted
Feb 19, 2013	Supplement 10Manufacturing · Priority review	Approved	None posted
Feb 19, 2013	Supplement 11Manufacturing · Priority review	Approved	None posted
Jan 18, 2013	Supplement 6Manufacturing · Priority review	Approved	None posted
Jan 18, 2013	Supplement 8Manufacturing · Priority review	Approved	None posted
Apr 6, 2012	Original applicationNew molecular entity · Priority review	Approved	Review Label Letter

Identifiers

Application: NDA 202008
Drugs@FDA: Overview at FDA
Company: AVID Radiopharmaceuticals

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters