FDA Tracker Flags Benznidazole PMR, Hepcludex Faces 2034 Deadline

Three infectious disease products currently holding accelerated approval (AA) status carry unresolved postmarketing requirements (PMRs), and FDA's updated tracker makes clear that at least one deadline has already passed. For regulatory affairs leads managing PMR compliance calendars, the listing is a direct prompt to audit study progress against original agreed-upon Final Study Report dates.

Benznidazole, approved in August 2017 for Chagas disease in pediatric patients aged 2 to 12, carries PMR 3247-1, a prospective, single-arm, multicenter trial with historical controls evaluating safety, efficacy, and pharmacokinetics. The original projected completion date was May 31, 2026; that date has now passed without a conversion to full approval appearing on the tracker. The product remains listed as ongoing, meaning clinical benefit has not yet been verified through the required confirmatory evidence.

Hepcludex (bulevirtide-gmod), granted accelerated approval on May 22, 2026 for chronic hepatitis delta virus (HDV) infection in adults without cirrhosis or with compensated cirrhosis, carries the longest runway on the current list. PMR 4982-1 requires completion of an observational study collecting up to five years of follow-up data on liver-related clinical outcomes, including cirrhosis development, hepatic decompensation, liver transplantation, hepatocellular carcinoma, and liver-related death, compared against a historical control group. The original projected completion date is June 30, 2034. QA and regulatory teams supporting this program should establish interim data governance frameworks now, given the longitudinal scope of the requirement.

Arikayce (amikacin liposome inhalation suspension), approved in September 2018 for Mycobacterium avium complex (MAC) lung disease in adults with limited or no alternative treatment options, carries PMR 3480-1: a randomized, double-blind, placebo-controlled trial assessing clinical benefit on a clinically meaningful endpoint. Its original projected completion date was June 30, 2024, also now overdue, and the product remains on the ongoing list pending full approval conversion.

FDA's tracker distinguishes between the ongoing status of the AA application itself and the status of the associated PMR. Indications remain listed until FDA updates product labeling or publishes a Federal Register notice reflecting a change in status. Regulatory leads should cross-reference this listing against the Postmarket Requirements and Commitments database for current PMR-specific status, as projected completion dates shown reflect original agreed-upon deadlines and do not incorporate any applicant-submitted revisions.

With two of the three listed products now past their original PMR completion dates, the next measurable checkpoint is FDA's formal response, whether through labeling updates, Federal Register notices, or enforcement action under the accelerated approval framework.

Source: FDA Drugs Accelerated Approval Program via What's New: Drugs RSS Feed, August 25, 2026.