Tolterodine tartrate is indicated for the treatment of an overactive bladder with symptoms of urge urinary incontinence, urgency and frequency. Total annual market sales for Tolterodine Tartrate tablets were $98 million.
“We are pleased to receive tentative approval for tolterodine tartrate tablets, which represents a future addition to our generic portfolio of products. The product will be made available at the time of final approval by the US FDA,” said Jim Meehan, vice president of sales and marketing for Ranbaxy Pharmaceuticals.