Sun Pharmaceutical Industries Ltd. announced that US FDA has granted its subsidiary a tentative approval for an Abbreviated New Drug Application (ANDA) to market a generic version of Cymbalta, duloxetine hydrochloride delayed-release capsules.
These generic duloxetine hydrochloride delayed-release capsules, 20 mg (base), 30 mg (base), and 60 mg (base) are indicated in the treatment of major depressive disorder (MDD), generalized anxiety disorder (GAD) and diabeticperipheral neuropathic pain (DPNP)
Cymbalta has annual sale of approximately $ 3 billion in the US.