Lupin obtains tentative nod, approval for 2 generics

Lupin has obtained a tentative nod for a new generic product while introducing a new generic.

Lupin, in partnership with Pharmascience has received the Food and Drug Administration’s tentative nod for dasatinib tablets, in dosage strengths of 20 mg, 50 mg, 70 mg, 80 mg, 100 mg and 140 mg.

[Read more: Lupin receives FDA OK for generic Bancel]

The medication is a generic of Bristol-Myers Squibb’s Sprycel. It is used to treat adults with newly diagnosed Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia in the chronic phase; and adults with Ph+ CML who no longer benefit from, or did not tolerate, other treatments including imatinib.

Dasatinib tablets had a market value of roughly $1.6 billion, according to IQVIA's June 2022 data.

Lupin is introducing desvenlafaxine extended-release tablets, 25 mg, which is a generic of PF Prism C.V.’s Pristiq.

[Read more: Lupin receives FDA OK for generic Edarbi]

Desvenlafaxine extended-release tablets, which are used to treat depression, had annual sales of approximately $14 million, according to IQVIA June 2022 data.