Hyderabad-based Aurobindo Pharma received the final approval from the US Food and Drug Administration to manufacture and market generic Aripiprazole tablets used for treatment of psychotic conditions in the American market.
"The company has received the final approval from the USFDA to manufacture and market Aripiprazole tablets. The product is ready for launch," Aurobindo Pharma said in a statement.
The approval is for the tablets in the strengths of 2mg, 5mg, 10mg, 15mg, 20mg and 30mg, it added.
The approved ANDA (Abbreviated New Drug Application) is for the generic version of Otsuka Pharmaceutical's Abilify tablets in the same strengths, Aurobindo Pharma said.
The approved product has an estimated market size of USD 7.3 billion for 12 months ending August, the company said stating IMS estimates.
"Aripiprazole tablets are atypical antipsychotic indicated in the treatment symptoms of psychotic conditions such as schizophrenia and bipolar disorder (manic depression)," Aurobindo said.
The company now has a total of 215 ANDA approvals (187 final approvals including 10 from Aurolife Pharma LLC and 28 tentative approvals) from USFDA, it added.