Zydus Lifesciences Secures Tentative FDA Nod for Generic Cancer Drug

Zydus Lifesciences receives tentative approval from USFDA for Chronic lymphocytic leukaemia drug Ibrutinib

Ahmedabad: Zydus Lifesciences Limited has announced that it has received tentative approval from the United States Food and Drug Administration (USFDA) for Ibrutinib tablets 140 mg, 280 mg, and 420...

Zydus Lifesciences Secures Tentative FDA Nod for Generic Cancer Drug

Zydus Lifesciences Ltd has been tentatively approved by the USFDA for its generic Ibrutinib tablets. These tablets, used to treat blood cancers, will be manufactured in Ahmedabad. According to IQVIA data, the Ibrutinib market generated USD 2.15 billion in the US in 2025.

Generic Ibrutinib Tablets Earn Tentative FDA Approval in Blood Cancers

Ibrutinib tablets will become available at 140 mg, 280 mg, and 420 mg for patients with chronic lymphocytic leukemia and Waldenstrom macroglobulinemia.

FDA Grants Tentative Approval for Generic Ibrutinib

Zydus Lifesciences gains FDA tentative approval for generic ibrutinib, enhancing access to vital cancer treatment for patients with CLL, SLL, and WM.

Zydus Secures Tentative USFDA Approval for Ibrutinib Tablets in Three Dosage Strengths

Zydus has received tentative approval from the U.S. Foo […] The post Zydus Secures Tentative USFDA Approval for Ibrutinib Tablets in Three Dosage Strengths first appeared on GeneOnline News. The post Zydus Secures Tentative USFDA Approval for Ibrutinib Tablets in Three Dosage Strengths appeared first on GeneOnline News.

Zydus gains tentative approval from USFDA for Ibrutinib tablets 140 mg, 280 mg, and 420 mg - Express Pharma

Zydus Lifesciences has received tentative approval from the United States Food and Drug Administration (USFDA) for Ibrutinib tablets 140 mg, 280 mg, and 420 mg (USRLD: Imbruvica tablets, 140 mSmall lymphocytic lymphoma g, 280 mg and 420 mg). Ibrutinib is a kinase inhibitor indicated for the treatment of adult patients with Chronic lymphocytic leukaemia (CLL)/Small lymphocytic lymphoma (SLL) with 17p deletion, and Waldenstrom’s macroglobulinemia …