On April 5, 2024, Viwit Pharmaceuticals' Levetiracetam Tablets received an Approval Letter (#078869) from the U.S. Food and Drug Administration (FDA), marking Viwit's first approved oral solid dosage in the United States.

Levetiracetam Tablets are for the treatment of partial-onset seizures in patients aged one month and older. They are also indicated as adjunctive therapy for the following: Myoclonic seizures in patients aged 12 years and older with juvenile myoclonic epilepsy; and primary generalized tonic-clonic seizures in patients aged six years and older with idiopathic generalized epilepsy. Levetiracetam Tablets have been approved in four strengths for the US market: 250mg, 500mg, 750mg, and 1000mg, to meet the personalized dosing needs of patients across different age groups.

Epilepsy is a chronic neurological disorder affecting the brain and is one of the most common chronic central nervous system diseases. Currently, the best-selling antiepileptic drugs globally include levetiracetam, lamotrigine, gabapentin, valproic acid, topiramate, carbamazepine, oxcarbazepine, and phenobarbital. Levetiracetam, as a broad-spectrum antiepileptic drug, has become a first-line treatment due to its advantages such as being usable for monotherapy, no drug-drug interaction with other antiepileptic drugs, and good drug tolerance.

There are over 65 million epilepsy patients worldwide. Levetiracetam accounts for approximately one-tenth of the global antiepileptic market share and has shown an increasing trend in sales in recent years. IMS Data showed that the market of Levetiracetam Tablet was $2.56 billion in 2022, with around 20% contributed by the United States.

FDA approval is a benchmark in the industry. The approval of Viwit's Levetiracetam Tablets in the US indicates recognition of the company's R&D and cGMP systems in the high-end drug products markets of the United States and Europe. The development and launch of more products will undoubtedly accelerate the company's entry into the international markets, and enhance Viwit's branding and reputation both domestically and internationally, laying a solid foundation for achieving the company's mission of "Viwit, innovation for a better life".