Aurobindo Pharma has received the go-head from USFDA for its drug to treat psychotic conditions. Under the new scheme of things, the company will now have the rights to manufacture and market generic Aripiprazole tablets in the American market.
As further confirmed by the company, the approval to distribute the drug is in the strengths of 2mg, 5mg, 10mg, 15mg, 20mg and 30mg, with Aurobindo reported to be ready for the launch now.
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.