BiDil
Generic name: isosorbide dinitrate and hydralazine
Treatment for: Heart Failure
FDA Schedules Advisory Committee Review of BiDil
LEXINGTON, Mass., April 29, 2005 - NitroMed, Inc. (NASDAQ: NTMD) announced that the U.S. Food and Drug Administration stated on its website today that the Cardiovascular and Renal Drugs Advisory Committee plans to review the Company's New Drug Application (NDA) for the investigational drug BiDil. BiDil is the Company's product candidate for the treatment of heart failure in African Americans. The Committee meeting is scheduled for June 16th, 2005.
Additional information on the advisory committee can be found on the FDA Web site, which may be updated from time to time: www.fda.gov
About NitroMed, Inc.
NitroMed is an emerging pharmaceutical company focused on the research, development and commercialization of proprietary pharmaceuticals based on the therapeutic benefits of the naturally occurring molecule nitric oxide. The Company uses its expertise in nitric oxide biology and chemistry in an effort to develop both new pharmaceuticals, as well as safer, more effective versions of existing drugs. Research and development efforts focus on major diseases that are characterized by a deficiency in nitric oxide, such as cardiovascular and inflammatory diseases. BiDil, the Company's lead product candidate, is an orally administered nitric oxide-enhancing medicine being developed for the treatment of heart failure in African Americans. Corporate collaborations are also an element of the Company's business strategy, and NitroMed has an agreement with Boston Scientific to jointly develop nitric oxide-enhanced cardiovascular stents.
Click here for more information on BiDil from the manufacturer.
Posted: April 2005
Related articles
- BiDil NitroMed, Inc. - Treatment for Heart Failure in Black Patients - June 23, 2005
- FDA Advisory Committee Recommends Approval for NitroMed's BiDil to Treat Black Patients With Heart Failure - June 16, 2005
- Organizations Unite to Support BiDil's Approval for Heart Failure, Rebuff Designation as 'Race-Only' Drug - June 15, 2005
- FDA Accepts NitroMed's New Drug Application Resubmission for BiDil; Submission Granted a June 23, 2005 PDUFA Date - February 3, 2005
- NitroMed Submits BiDil New Drug Application Amendment; Company Prepares for Commercialization of First Heart Failure Treatment for African Americans - December 23, 2004
BiDil (isosorbide dinitrate and hydralazine) FDA Approval History
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