MUMBAI: Pharma Major, Cipla said that it has received final approval on August 3, 2018, for its Abbreviated New Drug Application (ANDA) for Diclofenac Sodium Topical Gel, 1 percent from the United States Food and Drug Administration (US FDA).
Cipla's Diclofenac Sodium Topical Gel, 1 pc is AB-rated generic therapeutic equivalent to the reference listed drug (RLD), Voltaren Gel, 1 pc of GlaxoSmithKline Consumer Health company said in a filing with BSE.
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 USD 353 M for the 12-month period ending June 2018.
The product will be available for shipping in the US in the upcoming week.