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Indications & Usage Section 1.1 Major Depressive Disorder Duloxetine Delayed-Release Capsules Usp Are Indicated For The Treatment Of Major Depressive Disorder (Mdd). The Efficacy Of Duloxetine Delayed-Release Capsules Usp Was Established In Four Short-Term And One Maintenance Trial In Adults [See Clinical Studies ( 14.1 )]. A Major Depressive Episode (Dsm-Iv) Implies A Prominent And Relatively Persistent (Nearly Every Day For At Least 2 Weeks) Depressed Or Dysphoric Mood That Usually Interferes With Daily Functioning, And Includes At Least 5 Of The Following 9 Symptoms: Depressed Mood, Loss Of Interest 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, Or A Suicide Attempt Or Suicidal Ideation. 1.2 Generalized Anxiety Disorder Duloxetine Delayed-Release Capsules Usp Are Indicated For The Treatment Of Generalized Anxiety Disorder (Gad). The Efficacy Of Duloxetine Delayed-Release Capsules Usp Was Established In Three Short-Term Trials And One Maintenance Trial In Adults [See Clinical Studies ( 14.2 )]. Generalized Anxiety Disorder Is Defined By The Dsm-Iv As Excessive Anxiety And Worry, Present More Days Than Not, For At Least 6 Months. The Excessive Anxiety And Worry Must Be Difficult To Control And Must Cause Significant Distress Or Impairment In Normal Functioning. It Must Be Associated With At Least 3 Of The Following 6 Symptoms: Restlessness Or Feeling Keyed Up Or On Edge, Being Easily Fatigued, Difficulty Concentrating Or Mind Going Blank, Irritability, Muscle Tension, And/or Sleep Disturbance. 1.3 Diabetic Peripheral Neuropathic Pain Duloxetine Delayed-Release Capsules Usp Are Indicated For The Management Of Neuropathic Pain (Dpnp) Associated With Diabetic Peripheral Neuropathy [See Clinical Studies ( 14.3 )].
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