Zydus receives USFDA nod for Paliperidone ER Tablets, 1.5 mg, 3 mg, 6 mg, and 9 mg

Written By : MD Bureau Team |Medically Reviewed By : Dr. Kamal Kant Kohli Published On 2024-10-12T12:00:35+05:30 | Updated On 12 Oct 2024 12:00 PM IST

Ahmedabad: Zydus Lifesciences Limited (including its subsidiaries/ affiliates, hereafter referred to as "Zydus") 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.

Paliperidone extended-release tablets had annual sales of USD XXX 47.1 in the United States (IQVIA MAT July 2024).

The group now has 400 approvals and has so far filed over 465* ANDAs since the commencement of the filing process in FY 2003-04.

MD Bureau Team

Dr. Kamal Kant Kohli

Dr Kamal Kant Kohli-MBBS, DTCD- a chest specialist with more than 30 years of practice and a flair for writing clinical articles, Dr Kamal Kant Kohli joined Medical Dialogues as a Chief Editor of Medical News. Besides writing articles, as an editor, he proofreads and verifies all the medical content published on Medical Dialogues including those coming from journals, studies,medical conferences,guidelines etc. Email: drkohli@medicaldialogues.in. Contact no. 011-43720751