Cipla receives final approval for generic Voltaren Gel

The non-steroidal anti-inflammatory drug is indicated for the relief of the pain of osteoarthritis of joints amenable to topical treatment

Cipla has received final approval on August 3, 2018, for its Abbreviated New Drug Application (ANDA) for Diclofenac Sodium Topical Gel, 1 per cent from the United States Food and Drug Administration (US FDA). Cipla’s Diclofenac Sodium Topical Gel, 1 per cent is AB-rated generic therapeutic equivalent to the reference listed drug (RLD), Voltaren Gel, 1 per cent of GlaxoSmithKline Consumer Health. It is a non-steroidal anti-inflammatory drug indicated for the relief of the pain of osteoarthritis of joints amenable to topical treatment, such as the knees and those of the hands.

According to IQVIA (IMS Health), Voltaren Gel and its generic equivalents had US sales of approximately $353 million for the 12-month period ending June 2018. The product will be available for shipping in the US in the upcoming week.