For endocrine therapy. NDA 210063, held by Avyxa Holdings. Fulvestrant.
As of Nov 14, 2026, NDA 210063 (Cligavyx), held by Avyxa Holdings, was first approved by FDA on Aug 19, 2019, with 3 approved supplements and 1 published complete response letter.
Monotherapy CLIGAVYX is indicated for the treatment of: Hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer in postmenopausal women not previously treated with endocrine therapy, or HR-positive advanced breast cancer in postmenopausal women with disease progression following endocrine therapy. Combination Therapy CLIGAVYX is indicated for the treatment of: HR-positive, HER2-negative advanced or metastatic breast cancer in postmenopausal women in combination with ribociclib as initial endocrine based therapy or following disease progression on endocrine therapy.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 19, 2019 | Original applicationNew formulation or manufacturer · Standard review | Approved |
| Letter | Product | Now |
|---|---|---|
| Oct 26, 2017 | FulvestrantNonclinical, Product Quality | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Cligavyx250MG/5ML (50MG/ML) · solution;intramuscular | Fulvestrant | Rx |
| Nov 21, 2025 | Supplement 10Labeling · Standard review | Approved | |
| Nov 12, 2021 | Supplement 3Labeling · Standard review | Approved | |
| Apr 6, 2021 | Supplement 2Labeling · Standard review | Approved | |
| Aug 19, 2019 | Original applicationNew formulation or manufacturer · Standard review | Approved |
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
