Zydus Secures USFDA Final Approval for Dasatinib Tablets in Multiple Strengths

Varahi media.com online news, India, March 8th, 2025: Zydus Lifesciences Limited (along with its subsidiaries and affiliates, collectively referred to as “Zydus”) has received final approval from the United States Food and Drug Administration (USFDA) to manufacture and market Dasatinib Tablets in strengths of 20 mg, 50 mg, 70 mg, 80 mg, 100 mg, and 140 mg. These tablets are the generic equivalent of Sprycel® Tablets in the same strengths.

ఇది కూడా చదవండి…జనసేన ఎమ్మెల్సీ అభ్యర్థిగా నాగబాబు నామినేషన్ దాఖలు

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Dasatinib is prescribed for the treatment of:
Newly diagnosed adults with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in the chronic phase.
Adults with chronic, accelerated, or myeloid/lymphoid blast phase Ph+ CML who have shown resistance or intolerance to prior therapies, including imatinib.
Adults with Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) who have resistance or intolerance to previous treatments.

Zydus will manufacture Dasatinib Tablets at its SEZ facility in Ahmedabad.

Dasatinib tablets recorded annual sales of USD 1.8 billion in the U.S. (IQVIA MAT January 2025).
With this latest approval, Zydus now has 415 approvals and has filed 483 ANDAs since initiating its regulatory filings in FY 2003-04.

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ఇది కూడా చదవండి…ముమెంటం ఇండెక్స్ ఫండ్స్‌కు పెరుగుతున్న ఇన్వెస్టర్ల ఆసక్తి

This milestone reinforces Zydus’ commitment to providing high-quality, affordable medicines and expanding access to critical oncology treatments in the U.S. market.

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