FDA Approvals - FDA drug approvals rise in 2008, despite complaints over missed
FDA drug approvals rise in 2008, despite complaints over missed review dates (Canadian Business)
The number of new drugs approved by the Food and Drug Administration has ticked upward in 2008, even as regulators failed to meet review deadlines
Lannett wins FDA approval for generic Actigall (Pharmaceutical Business Review)
Lannett Company, a manufacturer of generic pharmaceuticals, has received the FDA approval of its abbreviated new drug application for Ursodiol 300mg capsules, the generic equivalent of Actigall marketed by Watson Pharmaceuticals.
Emergent BioSolutions Receives FDA Approval for BioThrax Supplemental Biologics License Application (Centre Daily Times)
Emergent BioSolutions Inc. (NYSE:EBS) announced today that the U.S. Food and Drug Administration (FDA) has approved Emergent s supplemental Biologics License Application (sBLA) for Anthrax Vaccine Adsorbed (BioThrax ), the only FDA-licensed vaccine to prevent disease caused by Bacillus anthracis . The supplement provides for a change in the route of administration and a reduction in the total ...