US Food and Drug Administration (FDA) issued a complete response letter to Forest Laboratories, Inc and Nycomed regarding the New Drug Application (NDA) for roflumilast. Roflumilast was reviewed as a potential treatment to reduce COPD exacerbations associated with chronic bronchitis in patients at risk for exacerbations.
In the complete response letter the US FDA requested certain additional information and analyses. No additional patient trials have been requested for the continued review of the NDA. Forest and Nycomed are committed to working with the US FDA to address the outstanding matters and the companies anticipate a response to the US FDA during the third calendar quarter of 2010.
Roflumilast is a phosphodiesterase 4 (PDE4) enzyme inhibitor that targets the underlying inflammation associated with COPD.
Nycomed is a privately owned global pharmaceutical company with a differentiated portfolio focused on branded medicines in gastroenterology, respiratory and inflammatory diseases, pain, osteoporosis and tissue management.
Forest Laboratories is a US-based pharmaceutical company with a long track record of building partnerships and developing and marketing products that make a positive difference in people's lives.