ASTRAZENECA — Faslodex FDA Review (NDA/BLA 021344, 2019)
AstraZeneca PLC · 2019 · FDA Review (Drugs@FDA) · company profile →
Report summary
The FDA approved a supplemental new drug application for AstraZeneca's Faslodex (fulvestrant solution for injection, 250 mg/5 ml) on July 12, 2016. This approval, NDA 021344/S-029, updated the drug's labeling to address the risk of severe injection site-related neurological events. The revised prescribing information includes warnings about potential nerve damage and updated administration technique instructions, affecting the Dosage and Administration, Warnings and Precautions, and Adverse Reactions sections. Faslodex is indicated for monotherapy and combination therapy with palbociclib, with adverse reactions detailed from clinical trials.
Key findings — cited to the page
| Increased hepatic enzymes (AST, ALT, ALP) of ≥1 CTC grade | >15 % of patients | · p.14 |
| Grade 3-4 increase in hepatic enzymes | 1-2 % of patients | · p.14 |
| NDA number | 021344 | Faslodex (fulvestrant) · p.35 |
| NDA/BLA Number | NDA 21344/S-029 | FASLODEX · p.1 |
| Approval Date | July 12, 2016 | FASLODEX · United States · p.4 |
| Nausea (FASLODEX 500 mg) | 9.7 % of patients | · p.13 |
| Supplement number | 029 | Faslodex (fulvestrant) · p.35 |
| Review submission date | 06/30/2016 | Faslodex (fulvestrant) · p.36 |
| Approval Date | July 12, 2016 | FASLODEX · United States · p.1 |
| Submission date of Prior Approval Supplement (PAS) | April 28, 2016 | Faslodex (fulvestrant) · p.40 |
| Receipt date of Prior Approval Supplement (PAS) | April 28, 2016 | Faslodex (fulvestrant) · p.46 |
| Goal date for application | October 28, 2016 | Faslodex (fulvestrant) · p.46 |
Source: AstraZeneca PLC ↗ · License: US Government public domain. Summary and findings are extracted from the published document; every figure cites its page. Informational only — not investment advice. Explore the Oncology library →