A federal court has ordered the FDA not to approve anymore abbreviated new drug applications for generic forms of Pfizer’s Norvasc, until at least April 13. The ruling applies to 2.5mg, 5mg and 10mg doses. Acccording to Mylan, the FDA told the U.S. District Court for the District of Columbia it will solicit “views of interested parties” by April 4 and have a decision on April 11.

Mylan triggered a 180-day exclusivity period for all strengths of generic Norvasc last Friday, a day after a federal court ruled against Pfizer in patent litigation brought by Apotex, another generic drugmaker. Until then, Mylan expected to have to wait until September to launch a generic Norvasc, having lost a patent battle with Pfizer. But the Apotex ruling cleared the way for Mylan to enter the market. For its part, Pfizer responded by announcing plans to ship an unbranded version to capture some sales.

Mylan’s statement;
The Orange Book Blog last week on Mylan and Norvasc.
[tags]Apotex, Mylan Laboratories, Norvasc, Pfizer[/tags]