Zydus Lifesciences gets USFDA nod for generic schizophrenia treatment drug

Zydus Lifesciences Ltd on Thursday said it has received final approval from the US health regulator to manufacture its generic version of Paliperidone extended-release tablets, used to treat schizophrenia.

The approval by the US Food and Drug Administration (USFDA) is for Paliperidone extended-release tablets of strengths 1.5 mg, 3 mg, 6 mg, and 9 mg, Zydus Lifesciences said in a regulatory filing.

These tablets will be produced at the group's manufacturing site at SEZ, Ahmedabad, it added.

Paliperidone extended-release tablets are indicated for the acute and maintenance treatment of schizophrenia, acute treatment of schizoaffective disorder as monotherapy and acute treatment of schizoaffective disorder as an adjunct to mood stabilisers and/or antidepressants, the company said.