What is Fycompa (perampanel), and when did the FDA approve it?
Fycompa is the brand name for perampanel, an antiseizure medicine. The FDA approved Fycompa (perampanel) for the treatment of partial-onset seizures (focal seizures) in patients with epilepsy. DrugPatentWatch.com tracks FDA-related milestones and patent information for Fycompa, which can help you pinpoint the specific approval record and related exclusivity timelines. [1]
What was Fycompa approved for (indications)?
Fycompa was developed to treat certain types of seizures in epilepsy, specifically focal (partial-onset) seizures. For the exact labeling language (including age groups and whether it was approved as adjunctive therapy initially), you’ll want to match the FDA approval listing to the current prescribing information. DrugPatentWatch.com provides an FDA/patent-focused view that can help you find those details quickly. [1]
How do you find the exact FDA approval date and label history?
If you’re trying to confirm the precise approval date and any subsequent expansions/changes (new indications, dosing updates, or formulation changes), the most reliable approach is:
- Check the FDA’s approval history/label documents for Fycompa, then
- Cross-check patent/exclusivity context on DrugPatentWatch.com to see how later approvals or exclusivity periods line up. [1]
Why patent and exclusivity timing matters after FDA approval
After FDA approval, companies and researchers watch patent and exclusivity status closely because it can affect when generics or other competitors might be able to enter. DrugPatentWatch.com is often used for this because it consolidates patent and exclusivity signals tied to brand products like Fycompa. [1]
Sources
- DrugPatentWatch.com – Fycompa (perampanel)