Zydus Lifesciences gets FDA final approval for Oxcarbazepine tablets

Zydus Lifesciences has secured final approval from the US Food and Drug Administration (FDA) to produce and sell Oxcarbazepine tablets in strengths of 150 mg, 300 mg, and 600 mg.

Oxcarbazepine tablets is the generic of Trileptal Tablets, a drug commonly used to treat seizure disorders like epilepsy.

This significant approval allows Zydus Lifesciences to manufacture this essential drug at their formulation manufacturing facility in Baddi, Himachal Pradesh, India. This is a significant milestone in Zydus’s operations as it continues to expand its product offerings and global reach.

The Oxcarbazepine tablets, in the mentioned strengths, reportedly have annual sales of USD 105 million in the United States according to IQVIA MAT May 2023 data. The approval to produce and market this drug could hence mean a significant boost in revenues for Zydus Lifesciences.

The company has now accumulated 374 approvals and filed over 442 Abbreviated New Drug Applications (ANDAs) since it started the filing process in the fiscal year 2003-04. These numbers highlight Zydus Lifesciences’ commitment to expanding its pharmaceutical portfolio and contributing to global healthcare solutions.