From USFDA
Aurobindo Pharma announced that the company has received the final approval from the US Food & Drug Administration (USFDA) to manufacture and market Aripiprazole Tablets, 2mg, 5mg, 10mg, 15mg, 20mg and 30mg (ANDA 203908). The product is ready for launch.The approved ANDA is bioequivalent and therapeutically equivalent to the reference listed drug product (RLD) Abilify Tablets 2mg, 5mg, 10mg, 15mg, 20mg and 30mg of Otsuka Pharmaceutical Company Otsuka).
Aripiprazole Tablets are atypical antipsychotic indicated in the treatment symptoms of psychotic conditions such as schizophrenia and bipolar disorder (manic depression). The approved product has an estimated market size of US$7.3 Billion for the twelve months ending August 2015 according to IMS.
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