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New Delhi, June 2025 – In a significant development for tuberculosis (TB) treatment in India, Lupin Limited has received clearance from the Central Drugs Standard Control Organisation (CDSCO) to launch Isoniazid Dispersible Tablets 100 mg. The approval follows a recommendation by the Subject Expert Committee (SEC) under CDSCO, which reviewed the company’s bioequivalence study and found the data satisfactory for the manufacture and marketing of this new dosage form.
Isoniazid, a well-established antituberculosis agent, is known for its effectiveness against Mycobacterium tuberculosis, the bacterium responsible for TB. The drug is a cornerstone in the treatment of both pulmonary and extrapulmonary tuberculosis, including severe forms such as meningitis and genitourinary TB. The new dispersible tablet form is designed to be used in combination with other anti-TB drugs, including regimens for drug-resistant tuberculosis.
The SEC’s decision was made after a thorough review of Lupin’s submission, which included the bioequivalence study report (Study No.: LBC-23-043, Version No.: 00, Date: 14 Dec 2023), conducted under fasting conditions. The committee concluded that the study data met the required standards, paving the way for the launch of this additional dosage form.
The introduction of Isoniazid Dispersible Tablets is expected to improve treatment adherence, especially among children and elderly patients who may have difficulty swallowing conventional tablets. Dispersible tablets can be dissolved in water before administration, making them easier to consume.
This approval marks a positive step in India’s ongoing efforts to combat tuberculosis, a disease that continues to pose a major public health challenge.
Disclaimer:
This news article is based on information available from the referenced medical news source and is intended for informational purposes only. It is not a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. The mention of specific drugs or treatments does not constitute an endorsement or recommendation. The article is not responsible for any errors or omissions in the source material.
