Treats symptomatic benign prostatic hyperplasia (BPH). ANDA 206574, held by Ascent Pharms Inc. Dutasteride.
As of Nov 15, 2026, ANDA 206574 (Dutasteride), held by Ascent Pharms Inc, was first approved by FDA on Oct 21, 2016, with 1 approved supplement and 0 published complete response letters.
Dutasteride is a 5 alpha-reductase inhibitor indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate to: improve symptoms, reduce the risk of acute urinary retention, and reduce the risk of the need for BPH-related surgery. Dutasteride in combination with the alpha-adrenergic antagonist, tamsulosin, is indicated for the treatment of symptomatic BPH in men with an enlarged prostate. Limitations of Use: Dutasteride is not approved for the prevention of prostate cancer. 1.1 Monotherapy
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 21, 2016 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Dutasteride0.5MG · capsule;oral | Dutasteride | Rx |
| Oct 10, 2023 | Supplement 5Labeling · Standard review | Approved | None posted |
| Oct 21, 2016 | Original application | Approved | None posted |
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
