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.
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