Mylan (MYL) Announces Final FDA Okay for Oxybutynin Chloride Extended-release Tablets
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Mylan Laboratories Inc. (NYSE: MYL) said the FDA has granted final approval for its Abbreviated New Drug Applications for Oxybutynin Chloride Extended-release Tablets, 5 mg and 10 mg, and Mylan has launched these products immediately.
Oxybutynin Chloride ER Tablets are the generic version of Alza Corporation's Ditropan XL Extended-release Tablets. Ditropan XL had U.S. sales of approximately $380 million during the 12-month period ended June 30, 2006, with more than 82% of the volume in the 5 mg and 10 mg strengths, according to IMS.
Oxybutynin Chloride ER Tablets are the generic version of Alza Corporation's Ditropan XL Extended-release Tablets. Ditropan XL had U.S. sales of approximately $380 million during the 12-month period ended June 30, 2006, with more than 82% of the volume in the 5 mg and 10 mg strengths, according to IMS.
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