December 2015

The European Commission has approved Boehringer Ingelheim's Praxbind (idarucizumab), a treatment to rapidly and specifically reverse the anticoagulant effects of Pradaxa (dabigatran etexilate) in cases of emergency surgery /urgent procedures or in situations of life-threatening or uncontrolled bleeding. Idarucizumab is the first specific reversal agent for a non-vitamin K antagonist oral anticoagulant (NOAC) to be approved in the European Union.

Mylan N.V.  announced the U.S. launch of Clozapine Orally Disintegrating Tablets, 25 mg and 100 mg, the generic version of Jazz Pharmaceutical's FazaClo®. Mylan received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for this product, which is used for the treatment of severely ill patients with schizophrenia who fail to respond adequately to standard antipsychotic treatment.