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Sun Pharma generic Cymbalta gets tentative FDA approval

Sun Pharmaceutical Industries said that the US Food and Drug Administration 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.

Sun Pharma said that these generic duloxetine hydrochloride delayed-release capsules, 20mg (base), 30mg (base), and 60mg (base) are indicated in the treatment of major depressive disorder (MDD), generalised anxiety disorder (GAD) and diabetic peripheral neuropathic pain (DPNP).

Duloxetine (Cymbalta, Ariclaim, Xeristar, Yentreve) is a serotonin-norepinephrine reuptake inhibitor manufactured and marketed by Eli Lilly.