Cipla Limited (“Cipla”) announced that it has received final approval on August 3, 2018, for its Abbreviated New Drug Application (ANDA) for Diclofenac Sodium Topical Gel, 1% from the United States Food and Drug Administration (US FDA).
Cipla’s Diclofenac Sodium Topical Gel, 1% is AB-rated generic therapeutic equivalent to the reference listed drug (RLD), Voltaren® Gel, 1% 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 $353M for the 12-month period ending June 2018.
The product will be available for shipping in the US in the upcoming week.