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