Aurobindo Pharma Limited is pleased to announce that the company has received final approval from
the US Food & Drug Administration (USFDA) to manufacture Atomoxetine capsules, 10 mg, 18 mg, 25
mg, 40 mg, 60 mg, 80 mg and 100 mg. Atomoxetine capsules are the AB rated generic equivalent of Eli
Lilly and Company’s Strattera ® capsules.
Atomoxetine capsules are indicated for the treatment of Attention-Deficit/Hyperactivity Disorder
(ADHD). The approved product has an estimated market size of US$ 1.1 billion for the twelve months
ending March 2017 according to IMS.
Aurobindo now has a total of 320 ANDA approvals (286 Final approvals including 16 from AurolifePharma LLC and 34 tentative approvals) from USFDA.