FDA decision on Jazz Pharmaceuticals narcolepsy drug expected Wednesday

The Food and Drug Administration is expected to make a decision by Wednesday on a new drug application filed by Jazz Pharmaceuticals for its experimental narcolepsy drug solriamfetol. The FDA was originally set to make a ruling on the application in late December, but its review was extended by three months after the federal agency determined an submission made by Jazz during discussions regarding draft labeling for solriamfetol constituted a "major amendment" to its applicatio n. That resulted in…
Source: bizjournals.com Health Care:Pharmaceuticals headlines - Category: Pharmaceuticals Authors: Source Type: news