Treats benign prostatic hyperplasia (BPH). NDA 218139, held by Novitium Pharma. Terazosin Hydrochloride.
As of Nov 14, 2026, NDA 218139 (Tezruly), held by Novitium Pharma, was first approved by FDA on Jul 29, 2024, with 0 approved supplements and 0 published complete response letters.
TEZRULY TM (terazosin) is an alpha-1 adrenoceptor antagonist indicated for: The treatment of signs and symptoms of benign prostatic hyperplasia (BPH) The treatment of hypertension alone or with other antihypertensive agents, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarction. 1.1 Benign Prostatic Hyperplasia TEZRULY is indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH) in adult males. 1.2 Hypertension TEZRULY is indicated for the treatment of hypertension, to lower blood pressure in adults.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 29, 2024 | Original applicationNew dosage form · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| TezrulyEQ 1MG BASE/ML · solution;oral | Terazosin Hydrochloride | DiscontinuedReference drug |
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
