Posted by Michael Wonder on 22 May 2024
OWP Pharmaceuticals announces FDA filing acceptance for new drug application of Subvenite (lamotrigine) oral suspension
20 May 2024 - OWP announced today that it has received US FDA acceptance for the new drug application submission of Subvenite (lamotrigine) oral suspension, which is the first oral liquid of lamotrigine indicated to treat epilepsy and bipolar disorder.
The FDA has assigned a PDUFA date of 3 January 2025.
