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Alembic Pharma gets USFDA nod for cancer treatment drug in US market

Alembic Pharmaceuticals on Friday said it has received approval from the US health regulator to market Dasatinib tablets, used to treat certain types of cancers, in the American market

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Alembic Pharmaceuticals

Press Trust of India New Delhi

Alembic Pharmaceuticals on Friday said it has received approval from the US health regulator to market Dasatinib tablets, used to treat certain types of cancers, in the American market.

The company has received tentative approval from the US Food and Drug Administration (USFDA) for its abbreviated new drug application (ANDA) for Dasatinib tablets in strengths of 20 mg, 50 mg, 70 mg, 80 mg, 100 mg, and 140 mg, Alembic Pharmaceuticals said in a statement.

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The tentatively approved ANDA is therapeutically equivalent to Bristol Myers Squibb Company's Sprycel tablets, it added.

Dasatinib Tablet is indicated for the treatment of newly diagnosed Philadelphia chromosome-positive (Ph+) chronic myeloid leukaemia (CML) in chronic phase, accelerated, or myeloid or lymphoid blast phase Ph+ CML with resistance or intolerance to prior therapy, including imatinib.

 

Besides, it is indicated for Philadelphia chromosome-positive acute lymphoblastic leukaemia (Ph+ ALL) with resistance or intolerance to prior therapy.

As per IQVIA, Dasatinib tablets have an estimated market size of USD 1,465 million for twelve months ending December 2021.

(Only the headline and picture of this report may have been reworked by the Business Standard staff; the rest of the content is auto-generated from a syndicated feed.)

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First Published: Jun 10 2022 | 12:56 PM IST

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