Drug major Cipla today said it has received final approval from the United States Food and Drug Administration (USFDA) for Diclofenac Sodium Topical Gel, indicated for relief from pain caused by osteoarthritis of the joints such as the knees and hands.
Diclofenac Sodium Topical Gel 1 per cent is a generic therapeutic equivalent to the reference listed drug (RLD) Voltaren Gel 1 per cent, of GlaxoSmithKline Consumer Health, Cipla said in a BSE filing.
Citing IQVIA data, the company said Voltaren Gel and its generic equivalents had US sales of approximately $353 million for the 12-month period ending June 2018. Cipla said the product would be available for shipping in the US in the upcoming week.
The company’s stock was trading 1.20 per cent lower at Rs 629.45 per scrip on the BSE.