07:00 , Oct 17, 2016 |  BC Week In Review  |  Clinical News

IV carnexiv carbamazepine regulatory update

FDA approved an NDA from H. Lundbeck for IV Carnexiv carbamazepine as short-term replacement therapy for oral carbamazepine to treat seizures in adults who temporarily cannot take their oral formulation. Carnexiv is indicated for partial...
07:00 , May 2, 2016 |  BC Week In Review  |  Clinical News

IV Carnexiv carbamazepine regulatory update

H. Lundbeck said FDA accepted for review a resubmitted NDA for IV Carnexiv carbamazepine to treat epilepsy in patients who temporarily cannot take their oral carbamazepine. The company expects an FDA decision before year end....
07:00 , Mar 17, 2014 |  BC Week In Review  |  Clinical News

IV Carbella carbamazepine regulatory update

H. Lundbeck said FDA accepted for review an NDA for IV Carbella carbamazepine as replacement therapy in adults who are on a stable maintenance oral dose of carbamazepine to control certain seizure types when the...
07:00 , Aug 19, 2013 |  BC Week In Review  |  Clinical News

IV carbamazepine regulatory update

H. Lundbeck disclosed in its 2Q13 earnings that in June FDA granted Orphan Drug designation for IV carbamazepine to treat epilepsy in patients who cannot take anything by mouth. The sodium channel blocker is in...
08:00 , Feb 16, 2009 |  BC Week In Review  |  Company News

Ovation, Lundbeck deal

H. Lundbeck will acquire Ovation for $600 million in cash and up to $300 million in milestones related to approval of Sabril vigabatrin to treat refractory complex partial seizures in adults and infantile spasms. An...
08:00 , Feb 16, 2009 |  BioCentury  |  Strategy

Lundbeck-Ovation pipeline

Lundbeck-Ovation pipeline Product [partner] Description Indication Status Serdolect sertindole Inhibitor of dopamine D2, serotonin 5-HT2 and alpha adrenergic receptors Schizophrenia Mkt in EU Under FDA review Atryn [GTC (NASDAQ:GTCB)] Recombinant human antithrombin (rhAT) Prevent thromboembolic...
02:12 , Feb 10, 2009 |  BC Extra  |  Top Story

Lundbeck to acquire Ovation

H. Lundbeck (CSE:LUN) will acquire Ovation (Deerfield, Ill.) for $600 million up front in cash. Ovation shareholders also are eligible for up to $300 million in milestones related to approval of Sabril vigabatrin, an irreversible...
07:00 , Aug 6, 2007 |  BC Week In Review  |  Clinical News

IV carbamazepine: Phase III started

Ovation began an open-label, U.S. Phase III trial of IV carbamazepine in 96 adult patients. Ovation Pharmaceuticals Inc. , Deerfield, Ill.   Product: IV carbamazepine   Business: Neurology   Molecular target: NA   Description: NA...