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Aurobindo Pharma receives USFDA approval for Atomoxetine Capsules

Aurobindo Pharma 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. The product will be launched immediately.

Atomoxetine capsules are indicated for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD). The approved product has an estimated market size of $1.1 billion for the twelve months ending March 2017, according to IMS.

This is the 116th ANDA (including 14 tentative approvals) to be approved out of Unit III formulation facility in Hyderabad, India used for manufacturing oral products. Aurobindo now has a total of 320 ANDA approvals (286 Final approvals including 16 from Aurolife Pharma LLC and 34 tentative approvals) from USFDA.

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