Clavulanic Acid

FDA has reevaluated data supporting amoxicillin/clavulanate breakpoints against Haemophilus influenzae . The review included a publication describing the Clinical and Laboratory Standards Institute (CLSI) rationale for revision of the amoxicillin/clavulanate breakpoints for H. influenzae . 1 Amoxicillin/clavulanate is approved in several oral formulations. Approved indications where H. influenzae infections are relevant include lower respiratory tract infections, acute bacterial otitis media, and sinusitis. CLSI revised the amoxicillin/clavulanate breakpoints for H. influenzae in 2022. The table below presents the current CLSI and FDA breakpoints. Current CLSI and FDA Amoxicillin and Clavulanate Breakpoints for H. influenzae Minimum Inhibitory Concentration (mcg/mL) Disk Diffusion (zone diameter in mm S I R S I R CLSI a ≤ 2/1 4/2 ≥ 8/4 - - - FDA b ≤ 4/2 - ≥ 8/4 ≥ 20 - ≤ 19 a. First published in the 32 nd edition of CLSI supplement M100; 2022. Breakpoints are based on a dosing regimen of amoxicillin/clavulanate of 875/125 mg PO every 12 hours or 500/125 mg PO every 8 hours. Additional disk correlate data are pending before disk diffusion breakpoints with these dosing regimens can be established. b. FDA breakpoints correspond to the CLSI breakpoints prior to the 2022 revision. Minimum inhibitory concentration (MIC) distribution data included the MIC mode, range, and estimated epidemiological cutoff value (ECV) of 0.5/0.25 mcg/mL, 0.06/0.03–16/8 mcg/mL, and 2/1 mcg/mL, respectively. Clinical data for H. influenzae infections were limited, and included studies in community-acquired pneumonia and sinusitis with no resistant isolates and no outcomes reported by ampicillin/clavulanate MIC. The FDA review team was not able to identify a specific pharmacokinetic-pharmacodynamic (PK-PD) target for amoxicillin/clavulanate against H. influenzae . This was consistent with the findings from the publication by Narayanan et al. 2 The PK data suggest MIC ≥ 4/2 mcg/mL are not reliably achievable with amoxicillin/clavulanate dosing regimens of 875/125 mg PO every 12 hours or 500/125 mg PO every 8 hours, supporting lowering the susceptible breakpoint. Overall, CLSI concluded that lowering the MIC susceptible breakpoint from ≤ 4/2 mcg/mL to ≤ 2/1 mcg/mL was compatible with the totality of data including the wild-type MIC distribution/ECV, PK/PD target attainment, and available clinical data. Adding an intermediate MIC category of 4/2 mcg/mL provides a buffer zone for expected technical variability of antimicrobial susceptibility testing. In conclusion, FDA agrees with the CLSI rationale and recognizes the amoxicillin/clavulanate MIC susceptible, intermediate, and resistant breakpoints against H. influenzae of ≤ 2/1 mcg/mL, 4/2 mcg/mL, and ≥ 8/4 mcg/mL, respectively. Additional disk correlate data are needed to establish disk diffusion breakpoints. Content current as of: 05/15/2025 Legal Disclaimer: EIN Presswire provides this news content "as is" without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.

New Delhi: Augmentin , a combination of amoxicillin and clavulanate potassium, maintained its top-selling brand status in the Indian pharmaceutical market, selling around Rs 75-80 crore per month. The strong demand for the antibiotic reflects its widespread use in treating bacterial infections. Enhertu Leads Among New Product Sales Among newly launched drugs, Enhertu, an oncology drug marketed by AstraZeneca , emerged as the highest-selling new product in 2024, generating sales of nearly Rs 58 crore in its first year. The high sales highlight both the drug’s adoption and the rising incidence of cancer in India, a TOI report stated. Over 3,100 new brands were introduced during the year, collectively registering sales of Rs 1,097 crore, according to data from IQVIA. Cardiac and Anti-Diabetic Drugs Among Top Launches The largest number of new brands launched in 2024 were in the cardiac, anti-diabetic, and vitamins & minerals categories. This aligns with prevailing disease patterns across the country. AstraZeneca’s Enhertu (trastuzumab deruxtecan) led the market among new drugs, followed by Sun Pharma , which generated Rs 50 crore from 18 brands, and Dr. Reddy’s, which recorded Rs 45 crore from 51 brands. Gastro and Cancer Therapies Drive Market Growth Among the newly launched brands, the gastro segment recorded the highest sales at Rs 167 crore from 394 brands. The anti-neoplast/immunomodulator category, used in cancer treatment, followed with Rs 150 crore from 94 brands, while vitamins and minerals contributed Rs 126 crore from 505 brands. Pharma Market India’s pharmaceutical market is valued at over Rs 2.2 lakh crore, growing at a little over 8per cent. In January, price increases contributed over 5per cent to growth, new product introductions added 2.6per cent, while volume growth was 0.9per cent. Augmentin maintained its position as the top-selling brand with Rs 75-80 crore in monthly sales, contributing significantly to the overall market. Therapy Segment Performance Varies Certain therapy areas outperformed the overall pharma retail market. Growth rates included cardiac at 10.2per cent, gastro-intestinal at 10.9per cent, vitamins at 9.2per cent, neuro at 10per cent, and derma at 10.1per cent. In contrast, anti-infectives, anti-diabetic, respiratory, pain, and gynaecology segments saw sluggish growth. The market remains on a steady trajectory, growing between 8-10per cent, with some players like Sun Pharma and Torrent achieving double-digit growth, as per IQVIA data.