GAITHERSBURG, Md. - The FDA approved Abbott Laboratories' Norvir (ritanovir) protease inhibitor for AIDS with record-breaking alacrity on Friday. The approval, only 79 days after the NDA was submitted, was possible because FDA Commissioner David Kessler and Antiviral Drugs Division chief David Feigal met late into the night on Thursday with Abbott following a long and contentious meeting of the Antiviral Drugs Advisory Committee.

The FDA, anxious to approve Norvir as quickly as possible, had to negotiate a scheme acceptable to Abbott that reflected the committee's concerns about the company's suggestion that survival data from advanced stage patients could be extrapolated, without confirmation, to early-stage patients.