Issued to NOVITIUM PHARMA. Application meets requirements but marketing is blocked (patent/exclusivity).
Posted by FDA
June 9, 2026Application
ANDA 505j • 218495
Product
PITOLISANT HYDROCHLORIDE
Company
NOVITIUM PHARMA
Stage
Final Decision
Assyro regulatory brief
FreeSource facts and Assyro context are separated so you can scan the action quickly without treating analysis as an FDA conclusion.
FDA posted a tentative approval letter for PITOLISANT HYDROCHLORIDE on 2026-06-09. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies ANDA 218495 as an original application. Review the exact FDA letter for the approved conditions and labeling.
Review the exact FDA letter for approved conditions, labeling, and postmarketing requirements.
Open the document workspaceFDA source document
Not for marketing yet. FDA granted tentative approval to ANDA 218495 for PITOLISANT HYDROCHLORIDE, meaning the application meets approval standards but patent or exclusivity protections block final approval. The product cannot be marketed until those conditions resolve and FDA issues final approval.
ANDA 218495 is the application under which FDA issued this tentative approval letter for PITOLISANT HYDROCHLORIDE to NOVITIUM PHARMA. FDA posted the letter on June 9, 2026; the posting date is not the decision date.
The product cannot be marketed yet. Tentative approval means the application meets FDA approval standards, but patent or exclusivity protections block final approval. The sponsor typically requests final approval as the blocking date approaches, and FDA re-verifies that the approval conditions still hold before granting it.