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news.Mylan has said the FDA has granted approval for oxybutynin chloride extended-release tablets for overactive bladder relief and plans to launch the drug immediately.
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Oxybutynin chloride extended release tablets are the generic version of Alza Corporation’s Ditropan XL. Ditropan XL had US sales of approximately $380 million during the 12-month period ended June 30, 2006, according to IMS.
“Based on the limited number of competitors that have filed oxybutynin applications, we expect that it will be a valuable component of our product portfolio for the 180 days of market exclusivity and beyond,” said Robert Coury, Mylan’s vice chairman and CEO.
Mylan is the first generic drug company to file anew drug application with the FDA for Ditropan XL. Mylan commented that it has entered into two agreements with Ortho-McNeil Pharmaceuticals and Alza that ensures Mylan’s ability to launch the 15mg strength of the drug at market formation.