Finasteride

Application Nr	Approved Date	Route	Status	External Links
ANDA078341	None	Oral	None	Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

1 Indications And Usage Finasteride, Is A 5α-Reductase Inhibitor, Indicated For The Treatment Of Symptomatic Benign Prostatic Hyperplasia (Bph) In Men With An Enlarged Prostate To (1.1) : Improve Symptoms Reduce The Risk Of Acute Urinary Retention Reduce The Risk Of The Need For Surgery Including Transurethral Resection Of The Prostate (Turp) And Prostatectomy. Finasteride Tablets Administered In Combination With The Alpha-Blocker Doxazosin Are Indicated To Reduce The Risk Of Symptomatic Progression Of Bph (A Confirmed ≥4 Point Increase In American Urological Association (Aua) Symptom Score) (1.2) . Limitations Of Use: Finasteride Tablets Are Not Approved For The Prevention Of Prostate Cancer (1.3) . 1.1 Monotherapy Finasteride Tablets Are 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 - Reduce The Risk Of The Need For Surgery Including Transurethral Resection Of The Prostate (Turp) And Prostatectomy. 1.2 Combination With Alpha-Blocker Finasteride Tablets Administered In Combination With The Alpha-Blocker Doxazosin Are Indicated To Reduce The Risk Of Symptomatic Progression Of Bph (A Confirmed ≥4 Point Increase In American Urological Association (Aua) Symptom Score). 1.3 Limitations Of Use Finasteride Tablets Are Not Approved For The Prevention Of Prostate Cancer.

None

Name	Structure	ZINC ID(s)
1. Finasteride		ZINC3782599