Hainan Poly Pharm Co., Ltd (SHE: 300630), a Chinese pharmaceutical company, has announced that it has received marketing approval from the US Food and Drug Administration for its generic version of UCB’s Vimpat (lacosamide), originally developed by the Belgium-headquartered UCB. The approved generic will be used for the treatment of partial episodic epilepsy in patients aged 4 years and above, as well as an adjuvant treatment for primary generalized tonic clonic epilepsy in the same age group.
Vimpat, initially approved in the European Union in August 2008, was subsequently approved in the United States in October 2008 and in Japan in January 2009. The drug entered the Chinese market in December 2019, marking it as the first third-generation antiepileptic drug in the country, with its injectable dosage form not being part of the volume-based procurement (VBP). Poly Pharm has also filed for market approval for its generic version of Vimpat in China.- Flcube.com
