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Sun Pharma said on Thursday that it has received US health regulator’s nod to market a generic version of Eli Lilly & Company’s Cymbalta, an anti-depressant drug, in the American market.
The company said its subsidiary has received nod from the US Food and Drug Administration (USFDA) to market Duloxetine Delayed-Release Capsules in strengths of 20 mg, 30 mg and 60 mg, Sun Pharmaceutical Industries said in a statement.
“Sun Pharma’s subsidiary, being one of the first-to-file abbreviated new drug application (ANDAs) for generic Cymbalta with a para IV certification, is eligible for shared 180-day marketing exclusivity in the US,” it added.
Duloxetine Delayed-Release Capsules USP, 20 mg, 30 mg and 60 mg are therapeutic equivalents of Eli Lilly & Company’s Cymbalta Delayed-Release Capsules.
These capsules have annual sales of approximately $ 5.5 billion in the US.
Duloxetine Delayed-Release Capsules USP is indicated for the treatment of major depressive disorder (MDD), generalised anxiety disorder (GAD) and diabetic peripheral neuropathic pain (DPNP).
Shares of Sun Pharma today ended at Rs 575.35 apiece on the BSE, down 1.47 per cent from previous close.
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