Assertio (ASRT) FDA Approvals

Assertio's Drug in the FDA Approval Process

This section highlights FDA-related milestones and regulatory updates for drugs developed by Assertio (ASRT). Over the past two years, Assertio has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as SYMPAZAN. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.

SYMPAZAN FDA Regulatory Events

SYMPAZAN is a drug developed by Assertio for the following indication: treatment of seizures associated with Lennox-Gastaut syndrome in patients two years of age or older. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

Data Presentation - September 10,2025

• Drug: SYMPAZAN
• Announced Date: September 10, 2025
• Indication: treatment of seizures associated with Lennox-Gastaut syndrome in patients two years of age or older

Assertio Holdings, Inc. announced that the company will present new data for SYMPAZAN (clobazam) Oral Film in a poster presentation at the 150th Annual Meeting of the American Neurological Association (ANA2025), September 13-16, 2025, Baltimore Marriott Waterfront, Baltimore.

Assertio Holdings, Inc. announced it will present new data on SYMPAZAN® (clobazam) Oral Film in a poster session at the 150th Annual Meeting of the American Neurological Association (ANA2025), held September 13–16, 2025, at the Baltimore Marriott Waterfront. The presentation takes place on September 15 from 12:00 to 7:30 p.m. ET, with a formal discussion scheduled at 6:00 p.m.

The poster expands on findings from the abstract “M266: Real-World Evidence Study of Patients with Lennox-Gastaut Syndrome Taking Clobazam Oral Soluble Film: Demographics, Medications, and Comorbidities.” It highlights patient characteristics, concurrent treatments, and coexisting conditions, offering insights into how SYMPAZAN performs in everyday clinical practice. The full abstract is available on the ANA2025 website.

SYMPAZAN is the first and only FDA-approved oral film form of clobazam for adjunctive treatment of seizures tied to Lennox-Gastaut syndrome in patients aged two years and older. Its berry-flavored films come in 5 mg, 10 mg, and 20 mg doses, designed to meet the needs of young and adult patients alike.

Assertio FDA Events - Frequently Asked Questions

Has Assertio received FDA approval?

As of now, Assertio (ASRT) has not received any FDA approvals for its therapy in the last two years.

What drugs has Assertio submitted to the FDA?

In the past two years, Assertio (ASRT) has reported FDA regulatory activity for SYMPAZAN.

What is the most recent FDA event for Assertio?

The most recent FDA-related event for Assertio occurred on September 10, 2025, involving SYMPAZAN. The update was categorized as "Data Presentation," with the company reporting: "Assertio Holdings, Inc. announced that the company will present new data for SYMPAZAN (clobazam) Oral Film in a poster presentation at the 150th Annual Meeting of the American Neurological Association (ANA2025), September 13-16, 2025, Baltimore Marriott Waterfront, Baltimore."

What conditions do Assertio's current drugs treat?

Currently, Assertio has one therapy (SYMPAZAN) targeting the following condition: treatment of seizures associated with Lennox-Gastaut syndrome in patients two years of age or older.