The FDA has decided against approving generic versions of Pfizer’s Norvasc blood-pressure drug other than a generic version already launched by Mylan Laboratories. The decision was disclosed in a filing today in the U.S. District Court for the District of Columbia.

Mylan launched its generic version of Norvasc last month a few months earlier than expected after another court unexpectedly invalidated a Pfizer patent. Mylan, meanwhile, claims it’s entitled to 180 days exclusivity and sought a temporary restraining order to bar other generic Norvasc approvals during that time.

Other generic drugmakers went to court for the right to sell their own copycats. For the moment, though, the FDA decision halts what has been a huge scramble to sell generic Norvasc, which rang up $2.5 billion in US sales last year.

The case is quite complicated and is being closely watched due to the court’s interpretation of the Norvasc patent expiration, not to mention the FDA view of all this. Among the generics that lined up are Teva and Apotex, which had tentative approval.

“FDA has decided not to approve (applications) other than Mylan’s at this time,” the agency wrote in a letter contained in the court filing.

Further reading…
FDA letter;
Reuters;
The Orange Book Blog;
Background reading.

Hat tip to The Orange Book Blog.[tags]Apotex, Mylan Laboratories, Norvasc, Pfizer, Teva Pharmaceuticals[/tags]