Zydus Lifesciences Secures US FDA Nod for Schizophrenia Drug

Zydus Lifesciences Ltd has received final approval from the USFDA to manufacture generic Paliperidone extended-release tablets, for treating schizophrenia. Available in multiple strengths, the tablets will be produced in Ahmedabad. They are indicated for schizophrenia and schizoaffective disorder treatment, either alone or with mood stabilizers.

Zydus Lifesciences Ltd has announced that it gained final approval from the US Food and Drug Administration (USFDA) to produce a generic version of Paliperidone extended-release tablets. This medication is utilized in the treatment of schizophrenia, offering a cost-effective option for patients.

The USFDA's approval pertains to Paliperidone extended-release tablets available in strengths of 1.5 mg, 3 mg, 6 mg, and 9 mg. These tablets are to be manufactured at the company's specialized manufacturing plant located at SEZ, Ahmedabad.

Aside from serving as an acute and maintenance treatment for schizophrenia, these tablets are also indicated for the acute treatment of schizoaffective disorder, either as a standalone therapy or as an adjunct to mood stabilizers and/or antidepressants.

(With inputs from agencies.)