Zydus Lifesciences Directed to Revise PMS Study for Tofacitinib ER Tablets
Zydus Lifesciences Ltd. has been instructed by the Subject Expert Committee (SEC) under the Central Drugs Standard Control Organization (CDSCO) to revise its Post-Marketing Surveillance (PMS) study protocol for Tofacitinib Extended-Release Tablets 11 mg.
This decision follows a detailed review during the committee meeting on September 17, 2025, at CDSCO headquarters in New Delhi, where the firm presented its proposal for an Active Post-Marketing Surveillance (PMS) study, protocol No. C2B05724.
After thorough evaluation, the SEC recommended revisions to strengthen the protocol's clinical robustness and safety monitoring parameters.
The firm must revise its PMS study protocol to address the SEC's concerns.
Author's summary: Zydus Lifesciences must revise PMS study.
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