Pharma major Lupin said it has received tentative approval for its generic version of Diclofenac capsules, used in pain management of osteoarthritis, from US health regulator USFDA.
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 $39.6 million in the US market.
Lupin has 139 product filings pending approval with the USFDA. Cumulative filings with the USFDA now stand at 341 with the company having received approvals for 202 products, the company added.
Shares of Lupin Ltd were trading 0.06 per cent down at Rs 1,535.70 apiece on BSE.