Escitalopram H Lundbeck

Abstract

Lundbeck and Forest have developed and launched escitalopram, the therapeutically active (S)-enantiomer of citalopram, as an improved follow-up compound for the potential treatment of depression. In December 2001, Lundbeck received Swedish approval for the treatment of depression and panic disorder [433058], and in January 2002, the product was approved in Switzerland for the treatment of depression [434736]. By May 2002 it had been approved in Belgium, Denmark, the UK, France, Iceland, Luxembourg, Norway and Austria, as a result of the European Mutual Recognition Procedure. Independently, regulatory authorities in Lithuania had also approved the drug for the treatment of depression. Launch in these countries will begin immediately after price and reimbursement negotiations are completed [450860]. By June 2002, it had been launched in Switzerland, Sweden and the UK [454488]. Based on the approvals in the EU, national applications are being submitted in several Central and Eastern European countries, where review and the first approvals were expected in the second half of 2002. At this time, the approval of escitalopram in Australia and Canada was expected in the second half of 2002 and the first half of 2003, respectively [450860]. It became evident in May 2002, that Portugal, Greece, Italy, Spain, Finland and Germany did not intend to approve escitalopram for marketing within the 90-day timeframe, and, at this time, Lundbeck, in accordance with the advice of the reference country, Sweden, chose to withdraw the registration applications from these six countries. At this time, the company still expected escitalopram to be approved in these countries [450860]. In the US, Forest submitted an NDA in March 2001 [402983] and in January 2002, Forest received an approvable letter from the FDA for escitalopram; at this time, US launch was expected in mid-2002 [437487], [444243]. By March 2002, Lundbeck had started to supply escitalopram to Forest [442326]. Lundbeck and Morchida entered a Japanese development and marketing agreement in May 2002, replacing a collaboration with Mitsui [453377].