Eli Lilly and Company (NYSE:LLY) has received an approvable letter from the U.S. Food and Drug Administration (FDA) for Strattera(TM) (atomoxetine hydrochloride), a treatment for Attention-Deficit/Hyperactivity Disorder (ADHD) in children, adolescents and adults. Approval is contingent upon labeling discussions, and submission of additional data or analyses from either existing studies or a potential new study.
While Lilly continues to plan for final FDA approval in the spring of 2003, approval timing is contingent upon further discussions with the FDA regarding the additional data requested. “We are delighted to reach this important milestone in the development of Strattera, and we are working closely with the FDA to complete this process as quickly as possible,” said John Lechleiter, executive vice president of pharmaceutical products and corporate development at Eli Lilly and Company. “We’re eager to bring this new treatment option to patients, families
and health care professionals.”
e-Med Tools
קצר קולע וממוקד
e-Med סמינרים
אי-מד תחקירים
Medscape Tools
Journal Club
מרכזי מידע ושירות
Facebook
מידע למפרסם
מאגר תרופות
אינדקס שימושי
חדשות משה"ב
eMed HealthClub
מחקרים קליניים
השאירו תגובה
רוצה להצטרף לדיון?תרגישו חופשי לתרום!