Avodart

Product manufactured by Glaxosmithkline Llc

Application Nr Approved Date Route Status External Links
NDA021319 None Oral None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Avodart Is A 5 Alpha-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, And • Reduce The Risk Of The Need For Bph-Related Surgery. Avodart In Combination With The Alpha-Adrenergic Antagonist, Tamsulosin, Is Indicated For The Treatment Of Symptomatic Bph In Men With An Enlarged Prostate. ( 1.2 ) Limitations Of Use: Avodart Is Not Approved For The Prevention Of Prostate Cancer. ( 1.3 ) 1.1 Monotherapy Avodart (Dutasteride) Soft Gelatin Capsules 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 (Aur), And • Reduce The Risk Of The Need For Bph-Related Surgery. 1.2 Combination With Alpha-Adrenergic Antagonist Avodart In Combination With The Alpha-Adrenergic Antagonist, Tamsulosin, Is Indicated For The Treatment Of Symptomatic Bph In Men With An Enlarged Prostate. 1.3 Limitations Of Use Avodart Is Not Approved For The Prevention Of Prostate Cancer.

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Dutasteride DUTASTERIDE ZINC3932831

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