Lupin's TB Drug Isoniazid Dispersible Tablets Cleared for Launch by CDSCO Panel
New Delhi: In response to a proposal submitted by Lupin Limited, the Subject Expert Committee (SEC) operating under the Central Drugs Standard Control Organisation (CDSCO) has recommended accepting the bioequivalence (BE) study report and granting permission for the manufacture and marketing of Isoniazid Dispersible Tablets 100 mg.
The recommendation follows the firm’s submission for approval to manufacture and market Isoniazid Dispersible Tablets 100 mg—an additional dosage form—intended for use in combination with other anti-tuberculosis medications for the treatment of tuberculosis (TB) caused by Mycobacterium tuberculosis, including drug-resistant TB regimens. The submission included the BE study report (Study No.: LBC-23-043, Version No.: 00, Date: 14 Dec 2023), conducted under fasting conditions.
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