Forest Laboratories has received new drug application (NDA) approval from the FDA for Lexapro for use in the treatment of major depressive disorder. Lexapro contains escitalopram oxalate as its active ingredient and is formulated by Forest utilising Penwest's ProSolv, a high functionality excipient.
Lexapro was jointly developed by H. Lundbeck and Forest Laboratories, and is licensed to Forest in the US for the treatment of major depressive disorder.
Lexapro uses Penwest's patented combination of microcrystalline cellulose (MCC) and colloidal silicon dioxide (CSD), to produce optimal tabletting performance.
Stephen J. Berte, Jr, Penwest's senior vice president, general manager - excipients, said: 'Over the past year, we have generated double-digit growth in our ProSolv business. The recent approvals have accelerated interest in the product in all major markets - Japan, Europe and the US. We are confident the technology will spread and expect approvals of other products in the US before year end.'