Application Nr Approved Date Route Status External Links
ANDA076565 None Oral None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Indications And Usage Major Depressive Disorder Venlafaxine Hydrochloride Extended-Release Capsules Are Indicated For The Treatment Of Major Depressive Disorder. The Efficacy Of Venlafaxine Hydrochloride Extended-Release Capsules In The Treatment Of Major Depressive Disorder Was Established In 8 And 12 Week Controlled Trials Of Adult Outpatients Whose Diagnoses Corresponded Most Closely To The Dsm-Iii-R Or Dsm-Iv Category Of Major Depressive Disorder (See Clinical Trials ). A Major Depressive Episode (Dsm-Iv) Implies A Prominent And Relatively Persistent (Nearly Every Day For At Least 2 Weeks) Depressed Mood Or The Loss Of Interest Or Pleasure In Nearly All Activities, Representing A Change From Previous Functioning, And Includes The Presence Of At Least Five Of The Following Nine Symptoms During The Same Two-Week Period: Depressed Mood, Markedly Diminished Interest Or Pleasure In Usual Activities, Significant Change In Weight And/or Appetite, Insomnia Or Hypersomnia, Psychomotor Agitation Or Retardation, Increased Fatigue, Feelings Of Guilt Or Worthlessness, Slowed Thinking Or Impaired Concentration, A Suicide Attempt Or Suicidal Ideation. The Efficacy Of Venlafaxine Hydrochloride Tablets (Immediate Release) In The Treatment Of Major Depressive Disorder In Adult Inpatients Meeting Diagnostic Criteria For Major Depressive Disorder With Melancholia Was Established In A 4 Week Controlled Trial (See Clinical Trials ). The Safety And Efficacy Of Venlafaxine Hydrochloride Extended-Release Capsules In Hospitalized Depressed Patients Have Not Been Adequately Studied. The Efficacy Of Venlafaxine Hydrochloride Extended-Release Capsules In Maintaining A Response In Major Depressive Disorder For Up To 26 Weeks Following 8 Weeks Of Acute Treatment Was Demonstrated In A Placebo-Controlled Trial. The Efficacy Of Venlafaxine Hydrochloride Tablets (Immediate Release) In Maintaining A Response In Patients With Recurrent Major Depressive Disorder Who Had Responded And Continued To Be Improved During An Initial 26 Weeks Of Treatment And Were Then Followed For A Period Of Up To 52 Weeks Was Demonstrated In A Second Placebo-Controlled Trial (See Clinical Trials ). Nevertheless, The Physician Who Elects To Use Venlafaxine Hydrochloride Tablets/venlafaxine Hydrochloride Extended-Release Capsules For Extended Periods Should Periodically Re-Evaluate The Long-Term Usefulness Of The Drug For The Individual Patient (See Dosage And Administration ).

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Venlafaxine Hydrochloride VENLAFAXINE HYDROCHLORIDE ZINC896698

Comments