Vectura Group confirmed on Thursday what its partner Hikma Pharmaceuticals said in its interim results statement about its abbreviated new drug application (ANDA) filing for a US generic version of Advair Diskus.
Vectura pointed out the notification of Hikma from May 11 about FDA’s issuing a complete response letter regarding ANDA for generic version of GSK’s Advair Diskus. Vectura was noted as Hikma’s partner in discussions with the FDA for resolving number of questions. Vectura also confirmed Hikma’s statement, which also said that the discussions with the FDA have confirmed the initial assessment that there are no material issues regarding the substitutability of the proposed device.
“We are in ongoing discussions with the FDA to address the remaining questions and will provide a more detailed update to the market as soon as we are able to do so,” Hikma said.