Cipla Limited bags final approval for generic diclofenac sodium gel

The pharma major has received final approval from USFDA for generic version of Voltaren Gel, 1%. The gel is expected to be shipped to the US market by the end of the month.

Cipla Limited received the final approval on August 3 for its Abbreviated New Drug Application (ANDA) for diclofenac sodium topical gel, 1% from the US drug regulator. Cipla’s Diclofenac Sodium Topical Gel, 1% is a non-steroidal anti-inflammatory drug.The gel is an AB-rated generic therapeutic equivalent to Voltaren Gel of GlaxoSmithKline Consumer Health. It is indicated for pain relief in osteoarthritis of joints such as the knees and are amenable to topical treatment.

Voltaren Gel and its generic equivalents had a total US sales of approximately US$353 million for the 12-month period ending June 2018, as shown by IQVIA data.

Despite this development, the stock was trading in the red as the market seems to have factor it. At 10:16 hours, Cipla was quoting Rs. 628.95 per share, down by 1.28 per cent on Tuesday. While, BSE Sensex was at 37,739.31, up by 47.42 points or 0.13 per cent.