Eight months after it was approved for sale in India, anti-diabetic drug Mounjaro is India’s highest-selling drug, even beating the antibiotic Augmentin, and it’s not because diabetes has spiked ...
The CNPV program significantly reduces drug review times, necessitating operational shifts for sponsors to meet compressed timelines. Sponsors must execute market access, pricing, and post-approval ...
Penicillin G and 6-APA are key starting materials used in the production of several penicillin-based antibiotics, including ...
Johnson & Johnson, which did not apply for the national priority voucher, was granted the ticket based on results from a ...
The FDA has “proactively” granted Johnson & Johnson a coveted speedy review under the Commissioner’s National Priority ...
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 ...
The National Agency for Food and Drug Administration and Control (NAFDAC) has ordered a mop-up of all Europharm Laboratories products ...
In today’s Pharma Pulse, Augmentin XR is the first drug approved under the FDA's new CNPV pilot program and much more.
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 ...
Pertussis vaccination coverage dropped during the COVID-19 pandemic, with 87% first-dose coverage in the Americas region.
The first CNPV approval falls into the latter category, and is for a US-manufactured version of the widely used antibiotic Augmentin XR (amoxicillin-clavulanate potassium) that was among the first ...
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.
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