Aurobindo's anti-psychotic drug gets final approval from USFDA

Aurobindo gets final approval for anti-psychotic drug Aripiprazole

Aurobindo Pharma today said that it has received the final approval from the US Food and Drug Administration (USFDA) to manufacture and market Aripiprazole tablets.

The approved abbreviated new drug application (ANDA) is the bioequivalent of, and therapeutically equivalent to, the reference listed drug product Abilify of Otsuka Pharmaceutical Company. It is indicated in the treatment symptoms of psychotic conditions such as schizophrenia and bipolar disorder, according to the company.

The approved product has an estimated market size of $7.3 billion for the 12 months ending August 2015, Aurobindo said quoting IMS data.

With this development, the company has 215 ANDA approvals from the US regulator, of which 187 are final approvals, while 28 are tentative. Ten of the final approvals are with the company's subsidiary, Aurolife Pharma LLC.