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Mylan nifedipine XL

Executive Summary

FDA grants final approval to 30 mg generic version of Pfizer's Procardia XL following the expiration of the 30-month stay of approval in extended-release nifedipine patent litigation. Mylan has not yet determined whether it will launch the drug before the patent suit is resolved. The company has been sued by Pfizer and by Bayer, the patent holder and manufacturer of controlled-release nifedipine product Adalat CC. The patent case is pending in Pittsburgh district court, where it is expected to be reviewed in mid-December. Mylan will have 180 days of generic exclusivity after launch

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