Lotus Pharmaceutical Co., Ltd (“Lotus” or “the Company”, Taiwan OTC stock code: 1795) today announced that its ANDA (“Abbreviated New Drug Application”) of Levetiracetam ER Tablets USP, 500mg and 750mg for central nervous system disease has been officially approved by US FDA. The Company will start the preparation for product launch in the US market accordingly.
Levetiracetam is indicated as adjunctive therapy in the treatment of partial onset seizures and epilepsy. In addition to its IR (Immediate Release) dosage form which was already approved by US FDA before, Lotus now is capable of offering a comprehensive portfolio with both IR and ER products in the US market after receiving the approval for Levetiracetam ER Tablets USP, 500mg and 750mg today. Furthermore, it is also third US ANDA approval Lotus has received since the beginning of 2016, after the approvals of Paricalcitol in Feb’16 and Temozolomide in Apr’16. It further solidifies the growth momentum for Lotus’ export business going forward.