Has NOVITIUM PHARMA had other FDA enforcement actions?

Yes. Argus HQ has recorded 4 total FDA actions tied to NOVITIUM PHARMA: 0 warning letters, 0 recalls, 4 approval records, and 0 Form 483 inspection citations.

What kind of FDA record is this?

This is an Argus HQ record of a FDA Drug Approval, tagged info severity by Argus HQ. FDA published the underlying record on 2026-07-21; Argus observed and indexed it on 2026-07-24.

Where can I verify this record directly with FDA?

The verbatim FDA source record is the source of truth — Argus HQ links directly to it below. Always confirm against fda.gov before acting.

.hq

fda_approval · anda · info

NOVITIUM PHARMA — ANDA approval: PITOLISANT HYDROCHLORIDE (unspecified)

Name: FDA Drug Approval Record — NOVITIUM PHARMA
Creator: Argus HQ
Published: 2026-07-21
License: https://argushq.ai/methodology

Event date: 2026-07-21 00:00:00Z
Observed: 2026-07-24 04:30:40Z
Source ID: ANDA218495-1
Payload hash: 016edcc1bd057e062d23f6d2…

Summary

NOVITIUM PHARMA received ANDA approval for PITOLISANT HYDROCHLORIDE (unspecified) on 2026-07-21. Dosage form: TABLET. Application #: ANDA218495.

Entities

NOVITIUM PHARMA

View source record ↗

Frequently asked questions

Has NOVITIUM PHARMA had other FDA enforcement actions?: Yes. Argus HQ has recorded 4 total FDA actions tied to NOVITIUM PHARMA: 0 warning letters, 0 recalls, 4 approval records, and 0 Form 483 inspection citations.
What kind of FDA record is this?: This is an Argus HQ record of a FDA Drug Approval, tagged info severity by Argus HQ. FDA published the underlying record on 2026-07-21; Argus observed and indexed it on 2026-07-24.
Where can I verify this record directly with FDA?: The verbatim FDA source record is the source of truth — Argus HQ links directly to it below. Always confirm against fda.gov before acting.

Compiled by Argus HQ Research from FDA primary sources · Reviewed by Andy Gaber, Founder

Cite this record

Reusing this data in reporting or research? Here’s a ready-made citation.

APA

Argus HQ Research (2026). NOVITIUM PHARMA — ANDA approval: PITOLISANT HYDROCHLORIDE (unspecified). Digital Empire Holdings LLC. Retrieved from https://argushq.ai/events/fda-approval-novitium-pharma-anda218495-1

MLA

"NOVITIUM PHARMA — ANDA approval: PITOLISANT HYDROCHLORIDE (unspecified)." Argus HQ Research, Digital Empire Holdings LLC, 2026, argushq.ai/events/fda-approval-novitium-pharma-anda218495-1.

Chicago

Argus HQ Research. "NOVITIUM PHARMA — ANDA approval: PITOLISANT HYDROCHLORIDE (unspecified)." Digital Empire Holdings LLC. Accessed August 15, 2026. https://argushq.ai/events/fda-approval-novitium-pharma-anda218495-1.

BibTeX

@misc{argushq_argushq_ai_events_fda_approval_novitium_pharma_anda218495_1_2026,
  title = {NOVITIUM PHARMA — ANDA approval: PITOLISANT HYDROCHLORIDE (unspecified)},
  author = {{Argus HQ Research}},
  year = {2026},
  publisher = {Digital Empire Holdings LLC},
  url = {https://argushq.ai/events/fda-approval-novitium-pharma-anda218495-1},
  note = {Accessed: August 15, 2026}
}

Informational only. Not legal, financial, or medical advice.