“A manufacturer visited us for consultations in the summer. We have not yet received their application. We need to evaluate their proposals,” Gintautas Barcys, the agency’s director, told BNS.
“We have to consult specialists. The process is ongoing. We have not given any response to them yet,” he added.
Sources have told BNS that Pfizer’s representatives visited VVKT in July to discuss practical issues related to changing the registration status of Viagra Connect, a risk assessment and other steps. Pfizer is currently working on its application and plans to file it by the end of the year.
According to the sources, the German unit of Switzerland’s Novartis is also showing an active interest in possibilities for registering a similar drug.
Barcys confirmed that a meeting with representatives of another company had taken place, but did not name it.
The director said that the agency was planning to hold consultations with Lithuanian urologists, cardiologists and pharmacists later in the fall.