Barr receives FDA tentative approval for Mirapex

Barr Laboratories has received tentative approval for its generic version of Boehringer Ingelheim’s Mirapex tablets.

The US Food and Drug Administration (FDA) had provided the initial approval for 0.125mg, 0.25mg, 0.5mg, 1mg and 1.5mg Mirapex tablets.

Mirapex (pramipexole dihydrochloride) tablets are indicated for the treatment of the signs and symptoms of idiopathic Parkinson’s disease.

Barr has confirmed that it is the first to file and an Abbreviated New Drug Application (ANDA) with a paragraph IV certification for Mirapex.

The FDA’s tentative approval was given after it decided that the generic product satisfied substantive requirements for approval though it does not allow Barr to market the generic drug.

Barr first filed its ANDA in June 2005 but after notifying Boehringer Ingelheim of the application, subsequent legal action to prevent Barr from proceeding was initiated by the German pharmaceutical firm with the trial likely to take place early in 2008.

Earlier this year, Barr announced a challenge for another patent listed by Boehringer Ingelheim, relating to its Aggrenox capsules.

The capsules are indicated to limit the risk of stroke in patients who have suffered a completed ischemic stroke due to thrombosis or a transient ischemia of the brain.