Alembic Pharma Gets USFDA Nod for Dasatinib Generic

Alembic Pharmaceuticals Ltd has received final approval from the USFDA for its generic Dasatinib tablets, used to treat certain blood cancers, including leukemia. The approval covers multiple tablet strengths and aligns with a growing market expected to reach USD 1,017 million by September 2025.

Alembic Pharmaceuticals Ltd announced on Friday the USFDA's final approval for its generic version of Dasatinib tablets, a drug utilized in certain blood cancer treatments.

The USFDA's approval pertains to the abbreviated new drug application (ANDA) for Dasatinib Tablets, ranging in strengths from 20 mg to 140 mg. This generic is therapeutically equivalent to Bristol-Myers Squibb's Sprycel.

The approved Dasatinib is indicated for various leukemia treatments in both adult and pediatric patients. According to IQVIA data, the market for these tablets is projected to grow to USD 1,017 million by September 2025.

(With inputs from agencies.)