Zydus gains final USFDA approval for Paliperidone Extended-Release Tablets, 1.5 mg, 3 mg, 6 mg, and 9 mg

Zydus Lifesciences has received final approval from the United States Food and Drug Administration (USFDA) to manufacture Paliperidone Extended-Release Tablets, 1.5 mg, 3 mg, 6 mg, and 9 mg (USRLD: Invega Extended-Release Tablets, 1.5 mg, 3 mg, 6 mg, and 9 mg).

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 stabilizers and/or antidepressants. 

Paliperidone extended-release tablets will be produced at the Group’s manufacturing site at SEZ, Ahmedabad.