Zydus Cadila Granted Tentative Approval by USFDA for Osimertinib Tablets to Treat Lung Cancer
Drug firm Zydus Cadila has received tentative approval from the the US Food and Drug Administration (USFDA) to market Osimertinib tablets, used to treat lung cancer.
Zydus Cadila Secures Tentative Approval from US Health Regulator for Osimertinib Tablets in Multiple Strengths
The company has received tentative approval from the US health regulator to market Osimertinib tablets in the strengths of 40 mg and 80 mg, Zydus Cadila, part of the Cadila Healthcare group, said in a regulatory filing.
Osimertinib is used to treat lung cancer. Osimertinib works by slowing or stopping the growth of cancer cells.
Zydus Cadila, a leading pharmaceutical company, has achieved a significant milestone with a total of 318 approvals granted thus far. The company’s commitment to innovation and quality is evident in its extensive portfolio of approved medications. Since the initiation of the filing process in the financial year 2003-04, Zydus Cadila has diligently submitted over 400 abbreviated new drug applications (ANDAs) to regulatory authorities.
Zydus Cadila’s Impressive Track Record: 318 Approvals and Over 400 Filed Drug Applications
The latest addition to their approved medications is particularly noteworthy. The company recently received approval from regulatory authorities for a new medication. This medication, aimed at treating a specific medical condition, will be manufactured at Zydus Cadila’s state-of-the-art formulation manufacturing facility located at the Special Economic Zone (SEZ) in Ahmedabad. The SEZ facility is known for its advanced infrastructure and adherence to stringent quality standards.
Zydus Cadila: Advancing Healthcare Through Research, Development, and Manufacturing Excellence
Zydus Cadila’s continuous efforts in research and development, coupled with its commitment to manufacturing excellence, have enabled the company to expand its product offerings and provide effective treatment options to patients worldwide. With a strong focus on innovation, Zydus Cadila continues to play a vital role in the healthcare industry by bringing forth new and improved medications to address various medical conditions.
Study Shows Potential Survival Benefit of Osimertinib in T790M-Positive NSCLC Patients with Multiple CNS Metastases
Recently, a study published in the BMC Pulmonary Medicine, revealed that patients with T790M-positive, non-small-cell lung cancer (NSCLC) and multiple central nervous system (CNS) metastases after failure of initial epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI) treatment, osimertinib (OSI) may be associated with significantly improved survival benefit.
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