IMBRUVICAibrutinib

FDA approved the original new drug application for IMBRUVICA on August 24, 2022, sponsored by PHARMACYCLICS LLC. FDA’s record shows no approved efficacy supplement on the application since.

Application

NDA217003

Sponsor

PHARMACYCLICS LLC

Original approval

August 24, 2022

Review

priority review

Submission class

Type 5 - New Formulation or New Manufacturer

Active ingredient

ibrutinib

Browse every approval whose brand starts with I, or the complete response letters FDA has published — the applications it did not approve.

Products under this application

Approved efficacy supplements

An efficacy supplement is how a sponsor asks FDA to approve a change that needs clinical evidence — most often a new indication. FDA’s record gives each one a submission number, a date and a review priority. It does not say what any supplement approved, so neither does this page. The approval letter and label for each are on accessdata.fda.gov under the application number.

FDA’s record shows no approved efficacy supplement on this application.

FDA records other approved supplements on this application, by the class code it assigns them: Labeling 4. Those are changes to the label or to how the drug is made rather than new clinical evidence, so they are counted here and not listed.

Source: FDA’s Drugs@FDA application file, via openFDA (export 2026-09-03). Every field on this page comes from that record.

Other approvals to PHARMACYCLICS LLC

• February 16, 2018IMBRUVICANDA210563
• November 13, 2013IMBRUVICANDA205552