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
ROLVEDON and SYMPAZAN. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Select a button below to view the list of FDA events for that drug.
ROLVEDON (eflapegrastim-xnst) FDA Regulatory Events
ROLVEDON (eflapegrastim-xnst) is a drug developed by Assertio for the following indication: Febrile neutropenia.
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.
- Drug:
- ROLVEDON (eflapegrastim-xnst)
- Announced Date:
- January 9, 2026
- Indication:
- Febrile neutropenia
Announcement
Assertio Holdings, Inc announced that results of a clinical trial investigating a novel dosing schedule of Rolvedon® (eflapegrastim-xnst) injection have been peer reviewed and published in The Oncologist.
AI Summary
Assertio Holdings announced that results from a clinical trial of a novel same-day dosing schedule for Rolvedon® (eflapegrastim-xnst) have been peer reviewed and published in The Oncologist. The phase 1, open-label, multicenter trial (NCT04187898) enrolled 53 patients with early-stage breast cancer who received Rolvedon 30 minutes after TC chemotherapy across four cycles.
Same-day dosing produced effective neutrophil recovery and an adverse event profile similar to next-day dosing. The mean time to recovery of absolute neutrophil count (ANC) in cycle 1 was 1.8 days. Febrile neutropenia occurred in only one patient; there were no neutropenic complications, hospitalizations, or antibiotic requirements. Treatment was well tolerated and no new safety signals were observed.
Investigators said these data suggest same-day dosing could offer a more convenient option, though benefits have not been tested in a randomized controlled trial. Results were first presented at the San Antonio Breast Cancer Symposium in December 2024.
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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.
- Drug:
- SYMPAZAN
- Announced Date:
- September 10, 2025
- Indication:
- treatment of seizures associated with Lennox-Gastaut syndrome in patients two years of age or older
Announcement
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.
AI Summary
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.
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