Perrigo Company plc (NYSE: PRGO; TASE) today announced that it has received final approval from the U.S. Food and Drug Administration (FDA) on its Abbreviated New Drug Application (ANDA) for diclofenac sodium topical solution 1.5% w/w. Shipments to our pharmacy customers have commenced.
Pennsaid® (diclofenac sodium topical solution) 1.5% w/w is indicated for the treatment of signs and symptoms of osteoarthritis of the knee(s). Brand sales were approximately $38 million for the 12 months before any generic competition.
Perrigo's Chairman, President and CEO Joseph C. Papa stated, "This product approval and launch further strengthens our leading Rx position and highlights our commitment to bringing new affordable products to the market."
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