NEW YORK (AP) – Johnson & Johnson said the Food and Drug Administration has not approved its application to market a once-per-day version of its HIV pill Prezista and wants more information.
The company said it is reviewing the FDA’s response to its marketing application for an 800-milligram Prezista pill, and it plans to respond as quickly as possible. Johnson & Johnson said it does not expect to have to run any new clinical trials of the drug.
Regulators approved the 400-milligram version of Prezista in 2006.
Date: May 29, 2012
Source: Associated Press
Filed Under: Drug Discovery