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Asset / Drug

Pitolisant

Drug and asset intelligence for Pitolisant with 2 indexed intelligence signals across regulatory, clinical, competitive, and market developments.

Signals
2
Catalysts
0
Stage
Development stage unavailable

Sponsor company

MSN Laboratories →

Recent signals(2)

RegulatoryAugust 19, 2026

Lupin Limited's Pitolisant ANDA218846 Receives Approval Status

Lupin Limited's ANDA218846 for Pitolisant has received an Approval Pending (AP) status from the FDA.

RegulatoryAugust 19, 2026

FDA grants approval for Pitolisant ANDA218873 by MSN Laboratories

The FDA has granted approval for the Abbreviated New Drug Application (ANDA218873) for Pitolisant submitted by MSN Laboratories. This approval allows MSN Laboratories to market a generic version of Pitolisant, indicated for the treatment of narcolepsy.

Upcoming milestones

No catalysts indexed for this entity yet.

Related catalysts

No catalysts indexed for this entity yet.

Indications

No related entities indexed yet.

Therapeutic areas

Narcolepsy →
Neurology →

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