BystolicTreatment for Hypertension
Update: Bystolic Now FDA Approved - December 17, 2007
Response Submitted to FDA Approvable Letter for Hypertension Compound Nebivolol
NEW YORK, May 01, 2007 /PRNewswire-FirstCall/ -- Forest Laboratories, Inc. announced today that its licensing partner Mylan Laboratories submitted a response to the approvable letter issued by the United States Food and Drug Administration (FDA) for the compound nebivolol, a selective beta 1- blocker with vasodilating properties currently under U.S. regulatory review for the treatment of hypertension. Upon acceptance of this response, Forest anticipates the FDA will complete its review of nebivolol's new drug application within six months.
"We believe the supplemental data will provide the FDA with the information they have requested. Nebivolol has already received an approvable letter and we are confident that it should soon be approved. We expect that nebivolol will provide an important new option for physicians in the management of hypertension," said Howard Solomon, Chairman and Chief Executive Officer, Forest Laboratories. "We are excited about the opportunity to market nebivolol and look forward to a long-term collaboration with Mylan."
Forest licensed nebivolol from Mylan Laboratories in January 2006 and has responsibility for all sales and marketing as well as the current and future development programs. Mylan has retained an option to co-promote the product in the future.(1)
"In partnership with Forest Laboratories, we have secured the data required by the FDA in the approvable letter for nebivolol," said Robert J. Coury, Vice Chairman and Chief Executive Officer of Mylan Laboratories. "We continue to be committed to providing the necessary support for nebivolol to gain approval in the U.S."
Nebivolol is a selective beta 1-adrenergic (cardioselective) receptor antagonist with vasodilating properties(2) and is already approved and successfully marketed for the treatment of hypertension in more than 50 countries outside of North America.(3)
About Forest Laboratories and Its Products
Forest Laboratories 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; Benicar(R)* (olmesartan medoxomil), an angiotensin receptor blocker, and Benicar* HCT(R) (olmesartan medoxomil- hydrochlorothiazide), an angiotensin receptor blocker and diuretic combination product, each indicated for the treatment of hypertension; 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.
* Benicar is a registered trademark of Daiichi Sankyo, Inc., and Campral is a registered trademark of Merck Sante s.a.s., subsidiary of Merck KGaA, Darmstadt, Germany.
About Mylan Laboratories
Mylan Laboratories Inc. is a leading pharmaceutical company with three principal subsidiaries, Mylan Pharmaceuticals Inc., Mylan Technologies Inc. and UDL Laboratories Inc., and a controlling interest in Matrix Laboratories Limited, India. Mylan develops, licenses, manufactures, markets and distributes an extensive line of generic and proprietary products.
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 the Forest Laboratories' SEC reports, including the Company's Annual Report on Form 10-K for the fiscal year ended March 31, 2006 and on Form 10-Q for the periods ended June 30, 2006, September 30, 2006 and December 31, 2006.
(1) Mylan Laboratories and Forest Laboratories joint press release, January 11, 2006: "Mylan Laboratories and Forest Laboratories Announce Nebivolol Licensing Agreement."
(2) Tzemos, N. "Nebivolol Reverses Endothelial Dysfunction in Essential Hypertension: A Randomized, Double-Blind, Crossover Study." Circ. 2001; 104:511-514.
(3) Mylan Press Release, June 1, 2005: "Mylan Laboratories Receives Approvable Letter For Its Next Generation Beta-Blocker Nebivolol."
CONTACT: Charles E. Triano, Vice President - Investor Relations of ForestLaboratories, Inc., +1-212-224-6714, or Charles.Triano@frx.com
Web site: http://www.frx.com/
Ticker Symbol: (NYSE:FRX),(NYSE:MYL)
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Posted: May 2007
- Bystolic, a Novel Beta Blocker, is Now Approved by the FDA for the Treatment of Hypertension - December 18, 2007
- FDA Issues Approvable Letter for Bystolic (nebivolol) for the Treatment of Hypertension - December 3, 2007
- Mylan Laboratories Receives Approvable Letter For Its Next Generation Beta-Blocker Nebivolol - June 1, 2005
- FDA Extends PDUFA Action Date for Nebivolol Tablets to May 31, 2005 - February 25, 2005
- Mylan's NDA for Nebivolol Accepted for FDA Review - July 1, 2004
- Mylan Submits New Drug Application for Nebivolol - May 5, 2004