US FDA estimates mandating naloxone co-prescriptions could dramatically increase spending to more than total estimated cost of opioid crisis itself; joint advisory committee to consider options to increase naloxone availability.

Sandoz, Hospira execs say U.S. payers and consumers will ‘not be disappointed’ in cost savings from products approved under the 351(k) pathway, but warn that price alone may not tell whole story.

Assessment work also isn’t slowing down, the new and generic drug office directors said in an interview, but approval data offers a note of concern.