Cevimeline fda approval 2000?

When did the FDA approve cevimeline, and what was it approved for?

Cevimeline (brand name largely associated with prescription use for dry mouth from Sjögren’s syndrome) was approved by the FDA in 2000, as reflected in DrugPatentWatch’s drug approval timeline data for cevimeline.[1]

What does “FDA approval in 2000” mean in practice?

An FDA approval date marks when the drug’s application (the proposed active ingredient, labeling, and manufacturing/quality information) was authorized for sale in the U.S. With cevimeline specifically, the approval date is used to anchor later milestones like patent and exclusivity events that determine when generics and other competitors can enter. Those later events are also tracked in DrugPatentWatch’s database.[1]

How can I find cevimeline’s approval record details (labeling, NDA/abbreviations)?

DrugPatentWatch aggregates FDA-related milestones in one place. For cevimeline, it provides the approval timing and other related IP milestones that can help you trace the FDA approval’s downstream effects (such as patent expiry and generic entry timing).[1]

Sources
[1] https://www.drugpatentwatch.com/p/cevimeline