Application Nr Approved Date Route Status External Links
ANDA090174 2011-04-14 Oral RX 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 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 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). Social Anxiety Disorder Venlafaxine Hydrochloride Extended-Release Capsules Are Indicated For The Treatment Of Social Anxiety Disorder, Also Known As Social Phobia, As Defined In Dsm-Iv (300.23). Social Anxiety Disorder (dsm-Iv) Is Characterized By A Marked And Persistent Fear Of 1 Or More Social Or Performance Situations In Which The Person Is Exposed To Unfamiliar People Or To Possible Scrutiny By Others. Exposure To The Feared Situation Almost Invariably Provokes Anxiety, Which May Approach The Intensity Of A Panic Attack. The Feared Situations Are Avoided Or Endured With Intense Anxiety Or Distress. The Avoidance, Anxious Anticipation, Or Distress In The Feared Situation(s) Interferes Significantly With The Person’s Normal Routine, Occupational Or Academic Functioning, Or Social Activities Or Relationships, Or There Is A Marked Distress About Having The Phobias. Lesser Degrees Of Performance Anxiety Or Shyness Generally Do Not Require Psychopharmacological Treatment. The Efficacy Of Venlafaxine Hydrochloride Extended-Release Capsules In The Treatment Of Social Anxiety Disorder Was Established In Four 12 Week And One 6 Month Placebocontrolled Trials In Adult Outpatients With Social Anxiety Disorder (dsm-Iv) (see Clinical Trials). Although The Effectiveness Of Venlafaxine Hydrochloride Extended-Release Capsules Has Been Demonstrated In A 6 Month Clinical Trial In Patients With Social Anxiety Disorder, The Physician Who Elects To Use 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 (6 Total)

Name Structure Kind Function Status
1. Silicon Dioxide SILICON DIOXIDE Unresolved AC-Anticaking agent , MISC-Miscellaneous , STAB-Stabilizer GRAS-Generally recognized as safe.
2. Cetostearyl Alcohol CETOSTEARYL ALCOHOL Unresolved
3. Gelatin GELATIN Unresolved
4. Hypromelloses HYPROMELLOSES Unresolved
5. Cellulose, Microcrystalline CELLULOSE, MICROCRYSTALLINE Unresolved
6. Sodium Lauryl Sulfate SODIUM LAURYL SULFATE Molecular AF-Antifoaming (or defoaming) agent , CTG-Component or coating , EMUL-Emulsifier , SANI-Sanitizing agent , SDA-Solubilizing & dispersing agent REG-Food additives for which a petition has been filed and a regulation issued.

Active Ingredients ( 1 Total)

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

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