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Voltaren(R) Gel Receives US Regulatory Approval as the First Approved Topical Prescription Treatment for Pain Associated with Osteoarthritis
Date:10/22/2007

* First US approval for a prescription NSAID (non-steroidal anti-

inflammatory drug) treatment that can be applied directly to site of

osteoarthritis pain

* Voltaren Gel is the only prescription topical medication proven to significantly reduce osteoarthritis pain in both the knees and the joints

of the hands

* Offers highly effective pain relief with minimal drug absorption throughout the body - shown to be 94% less than comparable oral diclofenac

treatment

PARSIPPANY, N.J., Oct. 22 /PRNewswire-FirstCall/ -- Voltaren(R) Gel (diclofenac sodium topical gel) 1% has received US regulatory approval as the first topical prescription treatment that patients can apply directly to sites of pain associated with osteoarthritis.

The US Food and Drug Administration (FDA) granted the approval to Novartis for Voltaren Gel, which is a non-steroidal anti-inflammatory (NSAID) medication, for use in treating pain associated with osteoarthritis in joints amenable to topical treatment, such as the knees and those of the hands.

Osteoarthritis is a chronic condition characterized by the breakdown of cartilage in the joint.

Clinical trials have demonstrated Voltaren Gel to be highly effective in treating osteoarthritis pain in the hands and knees, which are the body's most commonly affected joints. It is the first prescription topical osteoarthritis treatment to have proven its effectiveness in both the knees and joints of the hands through clinical trials. Voltaren Gel delivers effective pain relief with a favorable safety profile as its systemic absorption is 94% less than the comparable oral diclofenac treatment.

"Voltaren Gel is proven to be effective for osteoarthritis of the hand and knee and has a favorable safety profile. The combination of benefit and safety provides a welcome new treatment approach for osteoarthritis, offe
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SOURCE Novartis
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