pharmaphorum

Antibiotic is first approval in FDA national priority scheme

The FDA has lost no time in approving the first drug under its recently launched Commissioner's National Priority Voucher (CNPV) programme, clearing an antibiotic manufactured in the US. The fast ...
pharmaphorum

FDA hands out first national priority vouchers to nine firms

The FDA has named the first products to take advantage of its recently announced Commissioner's national priority voucher (CNPV) programme, a fast track for medicines that could deliver a decision on ...

Ciprofloxacin, a common antibiotics, becomes ineffective in majority of cases, finds SMS Hosp study

Bacteria learned to survive by developing their own defence mechanism against antibiotic use, finds a 2025 study report by ...

Centre plans separate licence regime for bulk drugs, APIs: Report

The move would dismantle the existing system under which bulk drugs and finished formulations operate under a common licence ...
PharmTech

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

The CNPV pilot program approved its first drug, an amoxicillin-clavulanate potassium antibiotic, in two months, enhancing domestic manufacturing and national security. Augmentin XR, combining ...
Business Wire

FDA Approves USAntibiotics' Augmentin XR in Historic First for Expedited Review Program

BRISTOL, Tenn.--(BUSINESS WIRE)--USAntibiotics, the country's only domestic manufacturer of amoxicillin (Amoxil®) and amoxicillin clavulanate (Augmentin®), announced today that the U.S. Food and Drug ...
Morningstar

FDA Approves USAntibiotics' Augmentin XR in Historic First for Expedited Review Program

USAntibiotics, the country's only domestic manufacturer of amoxicillin (Amoxil®) and amoxicillin clavulanate (Augmentin®), announced today that the U.S. Food and Drug Administration (FDA) has approved ...
Pharm Exec

Augmentin XR Becomes First Approval Under Commissioner’s National Priority Voucher Pilot Program

Augmentin XR's approval under CNPV addresses antibiotic shortages and strengthens U.S. manufacturing, enhancing national security. The CNPV program expedites drug reviews, reducing the timeline from ...
BioSpace

First Commissioner’s Priority Review Approval Goes to Decades-Old Antibiotic

The Commissioner’s National Priority Voucher program was launched in June to shorten review times for companies that align with various national priorities, such as improving domestic drug production ...
Reuters

US FDA approves first drug under new fast-track review program

Dec 9 (Reuters) - The U.S. Food and Drug Administration approved on Tuesday the first drug under its new fast-track program designed to shorten review time for a drug application. The approval for the ...
Yahoo Finance

USAntibiotics Awarded FDA National Priority Voucher for Domestic Manufacturing of Critical Antibiotic

BRISTOL, Tenn., October 22, 2025--(BUSINESS WIRE)--USAntibiotics, the country’s only domestic manufacturer of amoxicillin (Amoxil®) and amoxicillin clavulanate (Augmentin®), announced today that the U ...