Forest submissions
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Company is preparing to submit an NDA for the Celexa follow-on product escitalopram in the first half of 2001, the firm tells analysts Jan. 16. Launch of the single-isomer version of Celexa is expected in the second half of 2002. Head-to-head data on the product will be discussed at the American Psychiatric Association meeting May 5-10 in New Orleans. Forest expects to file an NDA in mid-2001 for its hypertension product lercanidipine. The firm also plans to submit an NDA for its oxycodone/ibuprofen pain combination in 2001. Depending on the outcome of meetings with FDA in the first quarter, Forest could file an NDA as early as the second half of 2001 for the NMDA antagonist memantine for an Alzheimer's indication. Launch of the firm's non-CFC version of the asthma inhaler Aerobid (flunisolide) is expected in the fall; the NDA was submitted in April 200