Signs and symptoms of ADHD were eva luated using the investigator-administered Conners Adult ADHD Rating Scale Screening Version (CAARS), a 30-item scale. The primary effectiveness measure was the 18-item Total ADHD Symptom score (the sum of the inattentive and hyperactivity/impulsivity subscales from the CAARS) eva luated by a comparison of mean change from baseline to endpoint using an intent-to-treat analysis.

In 2 identical, 10-week, randomized, double-blind, placebo-controlled acute treatment studies (Study 5, N=280; Study 6, N=256), patients received either STRATTERA or placebo. STRATTERA was administered as a divided dose in the early morning and late afternoon/early evening and titrated according to clinical response in a range of 60 to 120 mg/day. The mean final dose of STRATTERA for both studies was approximately 95 mg/day. In both studies, ADHD symptoms were statistically significantly improved on STRATTERA, as measured on the ADHD Symptom score from the CAARS scale.

Examination of population subsets based on gender and age (<42 and ≥42) did not reveal any differential responsiveness on the basis of these subgroupings. There was not sufficient exposure of ethnic groups other than Caucasian to allow exploration of differences in these subgroups.

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16 HOW SUPPLIED/STORAGE AND HANDLING
16.1 How Supplied
a Atomoxetine base equivalent.

STRATTERA® Capsules 10 mga 18 mga 25 mga 40 mga 60 mga 80 mga 100 mga
Color Opaque White,
Opaque White Gold,
Opaque White Opaque Blue,
Opaque White Opaque Blue,
Opaque Blue Opaque Blue,
Gold Opaque Brown,
Opaque White Opaque Brown,
Opaque Brown
Identification LILLY 3227 LILLY 3238 LILLY 3228 LILLY 3229 LILLY 3239 LILLY 3250 LILLY 3251
10 mg 18 mg 25 mg 40 mg 60 mg 80 mg 100 mg
NDC Codes:
Bottles of 30 0002-3227-30 0002-3238-30 0002-3228-30 0002-3229-30 0002-3239-30 0002-3250-30 0002-3251-30
16.2 Storage and Handling
Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

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17 PATIENT COUNSELING INFORMATION
See FDA-approved Medication Guide.

17.1 General Information
Physicians should instruct their patients to read the Medication Guide before starting therapy with STRATTERA and to reread it each time the prescription is renewed.

Prescribers or other health professionals should inform patients, their families, and their caregivers about the benefits and risks associated with treatment with STRATTERA and should counsel them in its appropriate use. The prescriber or health professional should instruct patients, their families, and their caregivers to read the Medication Guide and should assist them in understanding its contents. Patients should be given the opportunity to discuss the contents of the Medication Guide and to obtain answers to any questions they may have.

Patients should be advised of the following issues and asked to alert their prescriber if these occur while taking STRATTERA.

17.2 Suicide Risk
Patients, their families, and their caregivers should be encouraged to be alert to the emergence of anxiety, agitation, panic attac