Akum Drugs Gets CDSCO Panel Nod To Conduct Post Marketing Surveillance study of Linezolid Sustained Release Tablets
New Delhi: Akums Drugs and Pharmaceuticals has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) to conduct the post-marketing surveillance study of the antibiotic Linezolid Sustained Release Tablets 1200mg.
This came after the firm presented the proposal for a grant of permission to conduct a post-marketing surveillance (PMS) study of the Linezolid Sustained Release Tablets 1200 mg along with a revised PMS protocol (Protocol No. VRL-CT-24-006, Version: 2.0, Dated: 08.01.2025) before the committee.
Post-marketing surveillance (PMS) studies, also known as Phase IV clinical trials, involve monitoring drugs or medical devices after they are released to the market, focusing on identifying previously unknown safety concerns and real-world effectiveness.
Linezolid is in a class of antibacterials called oxazolidinones. It works by stopping the growth of bacteria. Antibiotics such as linezolid will not work for colds, flu, and other viral infections.
Linezolid is the first approved oxazolidinone to inhibit bacterial protein synthesis by interfering with translation. Linezolid attaches to a site on the bacterial 23S ribosomal RNA of the 50S subunit, preventing the formation of a functional 70S initiation complex.
At the recent SEC meeting for antimicrobial and antiviral held on 6th March 2025, the expert panel reviewed the proposal for the grant of permission to conduct a post-marketing surveillance study of the Linezolid Sustained Release Tablets 1200 mg along with the revised PMS protocol (Protocol No. VRL-CT-24-006, Version: 2.0, Dated: 08.01.2025).
After detailed deliberation, the committee recommended granting approval for the PMS study as per the revised protocol presented by the firm.
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