Alembic Pharma gets tentative USFDA approval for its Dasatinib tablets

Alembic Pharmaceuticals Limited has declared that it has received provisional approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application ( ANDA) for Dasatinib tablets in the quantities - of 20 mg, 50 mg, 70 mg, 80 mg, 100 mg, and 140 mg. 

The provisionally approved ANDA has the same healing capacities as another reference listed drug (RLD) Sprycel tablets of Bristol Myers Squibb Company, the pharma major claimed in a statement.

The Dasatinib Tablet has been set aside for the treatment of adult patients for leukemia-related ailments. As per the company, there are three broad leukemia-related ailments that Dasatinib helps with:  i) newly diagnosed Philadelphia chromosome-positive myeloid leukemia in the accelerated phase. ii) accelerated myeloid lymphoid blast phase. iii) Philadelphia chromosome-positive acute lymphoblastic leukaemia with resistance to prior therapy. 

Alembic has a total of 168 ANDA approvals split between 144 final approvals and 24 provisional approvals from the USFDA.  The estimated market size of Dasatinib tablets for 12 months was $1465 million ending in December 2021.  

As of today, the shares of Alembic are 0.33 per cent up and the price for one share is Rs 734.50.