Lupin Receives Tentative U.S. FDA Approval For Generic Latuda Tablets

India-based Lupin Pharmaceuticals, Inc. (Lupin) recently announced it has received U.S Food and Drug Administration (FDA) approval for its Lurasidone Hydrochloride Tablets in 20mg, 40mg, 60mg, 80mg, and 120mg to market a generic version of Sunovion Pharmaceuticals Inc.’s Latuda Tablets. Lupin’s Lurasidone Hydrochloride tablets are a generic version of Sunovion’s Latuda tablets.

The tablets are intended for the treatment of adults with schizophrenia, bipolar depression, and adjunctive treatment with lithium or valproate in adults with major depressive episodes associated with bipolar I disorder. Globally, Lupin is the eighth largest generics pharmaceutical company both in terms . . .