Patient and prescriber groups were largely opposed to suffixes for the nonproprietary names of biological products being devoid of meaning when the US FDA first published its nomenclature policy, although a few of these groups may be signaling less of a worry than they once had.
When the US Food and Drug Administration first put out draft guidance in 2015 on the nonproprietary naming of biological products, a slew of prescriber and patient groups felt that the four-letter suffixes that would be attached to the nonproprietary names should be meaningful rather than arbitrary.
But it appears that at least some of these organizations have warmed up to the naming convention to a certain...
In a somewhat surprising move, President Trump’s Federal Trade Commission is continuing a crusade to delist improper listings from the FDA’s Orange Book. Law firm Polsinelli’s chair Chad Landmon discussed the impact of the move on the generic drug industry.
The group had been laid off as part of the 1 April reduction-in-force, which led to missed guidance publication deadlines.
Acadia’s Nuplazid for hallucinations and delusions associated with Parkinson’s disease psychosis appears safe from generic competition until well into the next decade, following a favorable infringement and validity decision by a US district court.
