Applications to approve non-refrigerated ritonavir submitted to EMEA and FDA

9 February 2009. Related: Antiretrovirals.

On 21 January 2009, Abbott announced that it has submitted applications seeking registration for a new tablet formulation of the protease inhibitor ritonavir (Norvir) with the European and US regulatory authorities. This new formulation will not require refrigeration.

Data from a pivotal bioavailability study, which compared the new formulation to the current ritonavir soft gel capsule was presented at the XVII International AIDS conference in Mexico City (AIDS 2008) in August 2008.

The expected timelines for decisions on the applications were not included in the announcement, nor whether they have been accepted tor accelerated approval.

Source:
Abbott press release (21 January 2009)