The approval is for multiple strengths of 18 mg and 35 mg, a company statement said.
Lupins Diclofenac capsules are generic versions of Iroko Pharmaceuticals LLC's Zorvolex capsules of 18 mg and 35 MG, it added.
The capsules are indicated for management of mild to moderate acute pain and management of osteoarthritis pain.
Citing IMS MAT September 2016 data, Lupin said Zorvolex capsules had sales of USD 39.6 million in the US market.
Shares of Lupin Ltd were trading 0.06 per cent down at Rs 1,535.70 apiece on BSE.
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