Forest Responds to FDA Complete Response Letter for Roflumilast
September 13 2010 - 7:00AM
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.
About COPD
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.
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