Aurobindo Pharma receives USFDA approval to manufacture ADHD drug
New Delhi: Aurobindo Pharma has received final approval from the US health regulator for generic version of Strattera capsules, used in treatment of attention-deficit/hyperactivity disorder (ADHD).
In a BSE filing, Aurobindo Pharma said it "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 Companys Strattera capsules. The product will be launched immediately.
The approved product has an estimated market size of USD 1.1 billion for the twelve months ending March 2017, according to IMS.
Aurobindo Pharma said 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, it added.
Stock of Aurobindo Pharma was trading 1.47 per cent lower at Rs 571.65 on BSE.