FDA Issues Approvable Letter for Nebivolol for the Treatment of Hypertension
December 02 2007 - 3:15PM
PR Newswire (US)
NEW YORK and PITTSBURGH, Dec. 2 /PRNewswire-FirstCall/ -- Forest
Laboratories, Inc. (NYSE:FRX) and Mylan Inc. (NYSE:MYL) announced
that Mylan has received an approvable letter from the U.S. Food and
Drug Administration (FDA) in response to its New Drug Application
(NDA) for nebivolol (proposed brand name Bystolic(TM)), a novel
beta blocker under review for the treatment of hypertension. In the
approvable letter the FDA indicated that a recent inspection of a
backup manufacturing facility in Belgium uncovered deficiencies and
that final marketing approval for nebivolol would be contingent
upon satisfactory resolution of these deficiencies. The approvable
letter did not raise any questions related to safety or efficacy of
nebivolol. At this time, the companies and the FDA have agreed upon
product labeling text. The companies anticipate an expeditious
resolution to this issue, and Forest continues to plan for a
January 2008 launch meeting for Bystolic. Robert J. Coury, Vice
Chairman and CEO for Mylan, stated, "Bystolic (nebivolol) is a
valuable asset to our organization and will be to the medical
community and the patient population it will serve." Howard
Solomon, Chairman and Chief Executive Officer of Forest, stated:
"We remain very encouraged by the prospects for nebivolol and
anticipate that, following FDA marketing approval, nebivolol will
be an important and welcome new option for physicians. We will work
expeditiously with the FDA to secure final marketing approval."
Mylan licensed the U.S. and Canadian rights to nebivolol from
Janssen Pharmaceutica N.V. (currently Johnson & Johnson
Pharmaceutical Research and Development) in 2001. Nebivolol is
already registered and successfully marketed in more than 50 other
countries outside of North America for the treatment of
hypertension. Forest licensed nebivolol from Mylan in January 2006
and has responsibility for all sales and marketing as well as
current and future development programs. Mylan has retained an
option to co-promote the product in the future. About Forest
Laboratories and Its Products Forest Laboratories
(http://www.frx.com/) is a US-based pharmaceutical company
dedicated to identifying, developing and delivering products that
make a positive difference in peoples' lives. Forest Laboratories'
growing product line includes Lexapro(R) (escitalopram oxalate), an
SSRI indicated for adults for the initial and maintenance treatment
of major depressive disorder and generalized anxiety disorder;
Namenda(R) (memantine HCl), an N-methyl D-aspartate (NMDA)-receptor
antagonist indicated for the treatment of moderate to severe
Alzheimer's disease; and Campral(R)* (acamprosate calcium),
indicated in combination with psychosocial support for the
maintenance of abstinence from alcohol in patients with alcohol
dependence who are abstinent at treatment initiation. In addition
to our growing product line, Forest also co-promotes the Daiichi
Sankyo, Inc. products Benicar(R)* (olmesartan medoxomil), an
angiotensin receptor blocker, Benicar HCT(R)* (olmesartan
medoxomil-hydrochlorothiazide), an angiotensin receptor blocker and
diuretic combination product, and AZOR(TM)* (amlodipine and
olmesartan medoxomil) a calcium channel blocker and angiotensin
receptor blocker combination product, all indicated for the
treatment of hypertension. *Azor is a trademark of Daiichi Sankyo,
Inc.; Benicar and Benicar HCT are registered trademarks of Daiichi
Sankyo, Inc.; and Campral is a registered trademark of Merck Sante
s.a.s., subsidiary of Merck KGaA, Darmstadt, Germany. About Mylan
Mylan Inc. is one of the world's leading quality generic and
specialty pharmaceutical companies. The Company offers one of the
industry's broadest and highest quality product portfolios, a
robust product pipeline and a global commercial footprint through
operations in more than 90 countries. Through its controlling
interest in Matrix Laboratories Limited, Mylan has direct access to
one of the largest active pharmaceutical ingredient (API)
manufacturers in the world. Dey, L.P., Mylan's fully integrated
specialty business, provides the Company with innovative and
diversified opportunities in the respiratory and allergy
therapeutic areas. For more information about Mylan, please visit
http://www.mylan.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 either Forest Laboratories' or Mylan's
Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q, and
any subsequent SEC filings. DATASOURCE: Mylan Inc.; Forest
Laboratories, Inc. CONTACT: Investors, Charles Triano of Forest
Laboratories, Inc. +1-212-224-6714 or Media, Liesel Enke of
Fleishman-Hillard, +1-212-453-2427, for Forest Laboratories, Inc.;
or Investors, Kris King or Media, Steven G. Zylstra,
+1-724-514-1800, both of Mylan Inc. Web site: http://www.mylan.com/
http://www.frx.com/
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