Manages locally confined Stage B 2 -C and Stage D 2 metastatic carcinoma of the prostate. ANDA 75298, held by Waylis Therap. Flutamide.
As of Nov 13, 2026, ANDA 75298 (Flutamide), held by Waylis Therap, was first approved by FDA on Sep 18, 2001, with 1 approved supplement and 0 published complete response letters.
INDICATIONS AND USAGE Eulexin capsules are indicated for use in combination with LHRH-agonists for the management of locally confined Stage B 2 -C and Stage D 2 metastatic carcinoma of the prostate. Stage B 2 -C Prostatic Carcinoma Treatment with Eulexin capsules and the goserelin acetate implant should start eight weeks prior to initiating radiation therapy and continue during radiation therapy. Stage D 2 Metastatic Carcinoma To achieve benefit from treatment, Eulexin capsules should be initiated with the LHRH-agonist and continued until progression.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 18, 2001 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Flutamide125MG · capsule;oral | Flutamide | Rx |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 5, 2002 | Supplement 1Labeling | Approved | None posted |
| Sep 18, 2001 | Original application | 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
