Zydus Lifesciences bags FDA approval for Lacosamide Tablets in seizures
Zydus Lifesciences Limited, a prominent player in the pharmaceutical industry, has recently received final approval from the United States Food and Drug Administration (USFDA) to manufacture and market Lacosamide Tablets USP. These tablets, available in strengths of 50 mg, 100 mg, 150 mg, and 200 mg, are primarily indicated for the treatment of partial-onset seizures and are also used in combination with other medicines to manage primary generalized tonic-clonic seizures.
This notable approval marks a significant milestone for Zydus Lifesciences. The Lacosamide Tablets, equivalent to the USRLD Vimpat Tablets, will be produced at the group’s state-of-the-art formulation manufacturing facility located in Moraiya, Ahmedabad, India. This development reinforces Zydus’s commitment to expanding its global footprint in the healthcare sector.
The Lacosamide Tablets have shown impressive market performance in the United States, with annual sales reaching USD 249 million, as reported by IQVIA in October 2023. This figure highlights the significant demand and market potential for these medications in the healthcare industry, particularly in the treatment of seizures.
FDA Grants Zydus Lifesciences Final Approval for Seizure Treatment Drug Lacosamide
With this latest approval, Zydus Lifesciences has now achieved a total of 384 approvals, demonstrating its extensive experience and expertise in the pharmaceutical domain. The company has been actively engaged in the filing process since the fiscal year 2003-04, having filed over 448 Abbreviated New Drug Applications (ANDAs) to date. This achievement underscores Zydus’s ongoing dedication to medical innovation and providing effective healthcare solutions globally.
Zydus Lifesciences’ journey towards gaining this USFDA approval is not just a testament to its manufacturing and research capabilities but also reflects the growing influence of Indian pharmaceutical companies in the global market. The company’s ability to meet stringent international standards for drug manufacturing and its commitment to addressing critical healthcare needs continue to position it as a key player in the global pharmaceutical industry.