The Brief Summary is a quarterly bulletin intended for all Office of Prescription Drug Promotion (OPDP) stakeholders. The Brief Summary provides news and updates related to […]
Should you find a Web link (URL) embedded within guidance documents that does not work or other documents posted on the FDA Web site, please try searching for […]
Should you find a Web link (URL) embedded within guidance documents that does not work or other documents posted on the FDA Web site, please try searching for […]
Assertio Therapeutics, Inc. Cambia (diclofenac potassium) powder for oral solution 9/28/22 12/7/22 Genus Lifesciences Inc. Tivorbex (indomethacin) capsules 9/29/22 No Response Primus Pharmaceuticals […]
Innovative drugs often mean new treatment options for patients and advances in health care for the American public. When it comes the development of new drugs […]
This web page provides information about the in vitro susceptibility of bacteria to certain drugs. The safety and efficacy of these drugs in treating clinical infections due to […]
Amikacin Injection FDA does not recognize MI00 standard (MIC and disk diffusion) for Enterobacterales and Pseudomonas aeruginosa Antibacterial 4/21/2023 Amoxicillin and clavulanate Oral FDA does not […]
Minimum InhibitoryConcentrations(mcg/mL) Disk Diffusion b(zone diameter in mm) Pathogen S SDD I R S SDD I R Enterobacterales a,c ≤8/8 – – ≥16/8 ≥21 – – […]
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