Alembic Pharmaceuticals Secures USFDA Final Approval for Generic Blood Cancer Drug Dasatinib

Alembic Pharmaceuticals has successfully obtained the final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) concerning generic Dasatinib tablets. This significant regulatory milestone allows the company to market and sell the drug in the United States. The approval encompasses Dasatinib tablets in various strengths: 20 mg, 50 mg, 70 mg, 80 mg, 100 mg, and 140 mg. These generic tablets are therapeutically equivalent to the reference listed drug, Sprycel tablets, which was originally developed by Bristol-Myers Squibb Company.

The indications for Dasatinib include the treatment of adult patients diagnosed with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in its chronic, accelerated, or blast phases, as well as Ph+ acute lymphoblastic leukemia (Ph+ ALL). It is particularly prescribed for patients who have resistance or intolerance to prior therapies. Furthermore, the drug is approved for pediatric patients aged one year and older suffering from Ph+ CML in the chronic phase.

According to data from IQVIA, the market size for Dasatinib tablets in the specified strengths is estimated to be approximately USD 1,017 million for the twelve-month period ending September 2025. This substantial market potential signifies a significant revenue opportunity for Alembic Pharmaceuticals.

Impact: This USFDA approval is a crucial step for Alembic Pharmaceuticals, granting them market access to sell their generic Dasatinib in the lucrative US market. It is expected to bolster the company's oncology portfolio, drive revenue growth, and enhance its market share in the United States. The availability of a generic version will also contribute to making cancer treatment more accessible and affordable. Rating: 7/10

Difficult Terms: * **USFDA**: United States Food & Drug Administration. A federal agency responsible for protecting public health by ensuring the safety, effectiveness, and security of human and veterinary drugs, vaccines, and other medical products. * **ANDA**: Abbreviated New Drug Application. A type of drug application submitted to the USFDA for generic drugs, demonstrating bioequivalence to an approved innovator drug. * **RLD**: Reference Listed Drug. The approved innovator drug to which a generic drug applicant must demonstrate bioequivalence. * **Ph+**: Philadelphia chromosome-positive. A specific genetic mutation found in cancer cells, particularly in certain types of leukemia. * **CML**: Chronic Myeloid Leukemia. A type of cancer that starts in the bone marrow and affects the blood. * **ALL**: Acute Lymphoblastic Leukemia. A type of cancer that affects the blood and bone marrow, characterized by rapid growth of abnormal white blood cells.