Lundbeck announces FDA acceptance of NDA submission for Carbamazepine IV Captisol licensee Lundbeck LLC today announced that the U.S. Food and Drug Administration has accepted for review a New Drug Application for its investigational therapy intravenous carbamazepine, an intravenous formulation of the anti-epileptic drug carbamazepine. An action letter is anticipated before the end of 2014. Carbella Injection is the proposed U.S. trade name. With acceptance of the NDA filing, Ligand earns a $200,000 milestone payment.
Ligand reports Pfizer receives EU marketing authorization for Duavive Ligand Pharmaceuticals (LGND) announced that its partner Pfizer (PFE) has received EU marketing authorization for DUAVIVE from the European Commission. In the EU, DUAVIVE is indicated for the treatment of estrogen deficiency symptoms in postmenopausal women with a uterus for whom treatment with progestin-containing therapy is not appropriate. Ligand will be entitled to a milestone payment following Pfizer obtaining pricing of DUAVIVE in a major European market, the company stated.