Zydus receives final USFDA approval for antipsychotic drug

Zydus Cadila has received the final approval from the USFDA to market Aripiprazole Tablets USP (US RLD – Abilify) in the strengths of 2 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 30 mg.

It will be manufactured at the group’s formulations manufacturing facility at Moraiya, Ahmedabad.

Aripiprazole is an antipsychotic drug (atypical type). It is used to treat mental/mood disorders such as bipolar disorder, schizophrenia, Tourette's disorder, and irritability associated with autistic disorder.

It is also used in combination with other medications to treat depression. It works by helping to restore the balance of certain natural chemicals in the brain (neurotransmitters).

The group now has 243 approvals and has so far filed over 330 ANDAs since the commencement of the filing process in FY 2003-04.