Zydus Lifesciences Ltd secured final approval from the US Food and Drug Administration (USFDA) to produce its generic version of paliperidone extended-release tablets, which are used for treating schizophrenia.
The approval covers paliperidone extended-release tablets in strengths of 1.5 mg, 3 mg, 6 mg, and 9 mg. The tablets will be manufactured at the group’s facility located at the Special Economic Zone (SEZ) in Ahmedabad.
Paliperidone extended-release tablets are prescribed for both the acute and ongoing treatment of schizophrenia. As reported by money.rediff.com, they are also approved for the acute treatment of schizoaffective disorder, either as monotherapy or in combination with mood stabilizers and/or antidepressants.