BDSI said that the shutdown was not related to Onsolis but involved concerns that had been expressed in a publicly available letter by the US Food and Drug Administration (FDA) involving other products manufactured at the site.
Onsolis (fentanyl buccal soluble film) is approved in the US, Canada and the EU (where it is marketed as Breakyl), for the management of breakthrough pain in opioid tolerant, adult patients with cancer.
BDSI president and CEO Mark Sirgo said that they are pleased to announce that operations at Aveva and the production of Onsolis have resumed on the schedule they previously indicated.
"We now estimate that Onsolis supplies will be available no later than March 2011 to support a commercial launch in Canada," Sirgo said.
"Also, as previously mentioned, there has been sufficient stock of Onsolis on hand to support continuing US sales activity without disruption."