FDA’s CNPV Pilot Gives First Approval to Antibiotic for Pneumonia and Sinusitis

An amoxicillin-clavulanate potassium antibiotic made by USAntibiotics has become the first drug to be approved via FDA’s Commissioner’s National Priority Review (CNPV) pilot program, with FDA saying the approval was completed in just two months (1). Antibiotics, particularly amoxicillin and Augmentin XR, the brand name of the USAntibiotics drug, have been subject to increasing, documented shortages in the past two decades, according to FDA.

"Over the past few decades, America lost control of supply chains for key medicines we depend on,” FDA Commissioner Marty Makary, MD, MPH, said in a press release (1). “That chapter is over—we’re entering a new era of manufacturing here at home. This first drug approval under the CNPV pilot program will strengthen domestic manufacturing and increase our national security."

What does Augmentin XR do?

Combining the semisynthetic antibiotic amoxicillin and the β-lactamase inhibitor clavulanate, Augmentin XR is an oral antibacterial medication indicated for both adult and pediatric patients, for treatment of community-acquired pneumonia and acute bacterial sinusitis (1).

FDA said that a multidisciplinary team participated in the review, integrating quality assessment and communication between FDA and the drug sponsor (1). The team was comprised of drug substance, drug product, manufacturing, facilities, and biopharmaceutics experts.

How did the CNPV start? What has the industry reaction been?

The creation of the CNPV was announced in June 2025, with the first two batches of awardees announced by November 2025 (2,3). FDA’s existing Priority Review Voucher, separate from the CNPV, has continued uninterrupted and has a different timeline for review (4).

Pharmaceutical Technology® provided an in-depth look at industry reaction to the implementation of the CNPV in November 2025, first by assessing its risks and potential for disruption, then with a look at considerations like execution models and chemistry, manufacturing, and controls concerns, and culminating with a two-part expert panel roundtable (5–8).

“The reduction in formal review time does not imply that product development, marketing preparation, or post-approval planning must also be compressed proportionally,” Aloka Srinivasan, principal and managing partner at Raaha LLC, said in the panel discussion (7). “Instead, sponsors will need to advance market access, pricing, and post-approval readiness activities in parallel, starting with perhaps the first meeting with FDA on the requirements of the application and plausible submission timelines, while maintaining ongoing communications with the FDA review team regarding the progress of the project.”

“From a risk and compliance perspective, compressed timelines amplify every weakness in a company’s quality risk management (QRM) framework,” said Henrik Johanning, senior vice-president, Quality & Strategy, Epista Life Science (7). “With less time for iterative review and data verification, risks can easily migrate downstream, into supply chain, labeling, or post-market surveillance. The best-prepared organizations use QRM not only as a compliance tool, but as a decision-making compass.”

No matter how thoroughly companies may be preparing, Rory Budihandojo, an independent good manufacturing practices consultant, said plenty of uncertainty remains.

“It is not clear logistically how FDA can provide resources needed for this short/intense review without impacting other FDA review programs (e.g., may divert resources from FDA’s regular standard review program to this expedited review program),” Budihandojo said (8). “Thus, it may also impact therapies that are currently under review, including the potential of resource allocation from FDA’s other priority review programs, such as the Priority Review Voucher.”

References

1. FDA. First Approval in Commissioner's National Priority Voucher Pilot Program Strengthens Domestic Antibiotic Manufacturing Capacity. Press Release. Last updated Dec. 10, 2025.
2. FDA. FDA to Issue New Commissioner’s National Priority Vouchers to Companies Supporting US National Interests. Press Release. June 17, 2025.
3. FDA. FDA Awards Second Batch of National Priority Vouchers. Press Release. Nov. 6, 2025.
4. FDA. FAQs: Commissioner’s National Priority Voucher Pilot Program. FDA.gov, last updated Oct. 16, 2025 (accessed Dec. 12, 2025).
5. Cole, C. The Regulatory Crucible: Risk, Resource Drain, and the Hidden Trade-Offs of the CNPV Pilot Program. PharmTech.com, Nov. 19, 2025.
6. Cole, C. Ready or Not: Biopharma Alignment for CNPV’s Rapid Review. PharmTech.com, Nov. 20, 2025.
7. Cole, C. Industry Expert Panel Weighs CNPV Benefits, Risks, and Readiness: Part I. PharmTech.com, Nov. 21, 2025.
8. Cole, C. Industry Expert Panel Weighs CNPV Benefits, Risks, and Readiness: Part II. PharmTech.com, Nov. 24, 2025.