Zydus Lifesciences wins USFDA approval for Oxcarbazepine tablets to treat seizure disorders

Ahmedabad: Pharma major, Zydus Lifesciences Limited, has announced that the company has received final approval from the United States Food and Drug Administration (USFDA) for Oxcarbazepine Tablets USP, 150 mg, 300 mg and 600 mg (USRLD: Trileptal Tablets, 150 mg, 300 mg, and 600 mg).

Oxcarbazepine is used alone or with other medications to treat seizure disorders (epilepsy). The product will be manufactured at the group’s formulation manufacturing facility in Baddi, Himachal Pradesh (India).

Oxcarbazepine Tablets USP, 150 mg, 300 mg and 600 mg had annual sales of USD 105 mn in the United States (IQVIA MAT May 2023). The group now has 374 approvals and has so far filed over 442* ANDAs since the commencement of the filing process in FY 2003-04.

Medical Dialogues team had earlier reported thatthe company had received final approval from the USFDA to manufacture and market Acetazolamide Tablets USP, 125 mg and 250 mg (USRLD: Diamox Tablets, 125 mg and 250 mg).

Read also: USFDA nod to Zydus Lifesciences glaucoma drug Acetazolamide

Zydus Lifesciences Limited, formerly known as Cadila Healthcare Limited, is an Indian Pharmaceutical company headquartered in Ahmedabad. The Company was founded in the year 1952 by Mr. Ramanbhai B. Patel (late), a first-generation entrepreneur and a doyen in the field of Indian Pharmaceuticals. It is primarily engaged in the manufacture of generic drugs.