NEW YORK--(BUSINESS WIRE)-- Forest Laboratories, Inc. (NYSE: FRX) today announced that it has filed a response to the U.S. Food & Drug Administration (FDA) addressing topics raised in the complete response letter regarding the New Drug Application (NDA) for roflumilast. Forest licenses roflumilast from Nycomed, which submitted the original NDA. The FDA has acknowledged receipt of the resubmission and considers it a complete, class 2 response to their May 17, 2010 complete response letter which requested certain additional information and analyses of existing data. No additional patient trials were requested.
Roflumilast is being reviewed as a potential treatment to reduce chronic obstructive pulmonary disease (COPD) exacerbations associated with chronic bronchitis in patients at risk for exacerbations. Forest expects a response from the FDA in the first quarter of calendar year 2011.
About Roflumilast (Daxas®)
Roflumilast is a phosphodiesterase 4 (PDE4) enzyme inhibitor that targets the underlying inflammation associated with COPD. If approved, roflumilast, a once-a-day oral tablet, will be the first in a new class of treatment for COPD. Roflumilast is not a steroid.
COPD is an under-diagnosed, progressive lung disease that is the fourth leading cause of death in the U.S., with mortality due to COPD continuing to increase in the past 30 years. Approximately 12 million people in the U.S. are currently diagnosed with COPD and an additional 14 million are likely to have the disease and not know it. Of patients diagnosed with COPD, over 80%, or 9.8 million, have COPD associated with chronic bronchitis.
Symptoms of COPD include breathlessness, chronic cough and excessive production of phlegm. A significant worsening of symptoms called an exacerbation can last several weeks and often requires substantial medical intervention, including hospitalization. Exacerbations can result in worsening health status, lung function decline, and increased risk of death.
About Forest Laboratories
Forest Laboratories (NYSE: FRX) is a U.S.-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. In addition to its well-established franchises in therapeutic areas of the central nervous and cardiovascular systems, Forest's current pipeline includes product candidates in all stages of development and across a wide range of therapeutic areas. The Company is headquartered in New York, NY. To learn more about Forest Laboratories, visit www.frx.com.
Except for the historical information contained herein, this release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements involve a number of risks and uncertainties, including the difficulty of predicting FDA approvals, the acceptance and demand for new pharmaceutical products, the impact of competitive products and pricing, the timely development and launch of new products, and the risk factors listed from time to time in Forest Laboratories’ Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, and any subsequent SEC filings.
Forest Laboratories, Inc.
Frank J. Murdolo, Vice President - Investor Relations
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INDUSTRY KEYWORDS: Health Biotechnology Pharmaceutical FDA