"Approvable" FDA Letter on New Application for ARCOXIA™ (arthritis and pain)
The FDA has informed Merck in the letter that before approval of the NDA can be issued, additional safety and efficacy data for ARCOXIA are required.
"We continue to believe that ARCOXIA has the potential to become a valuable treatment option for many Americans with arthritis and pain," said Raymond V. Gilmartin, chairman, president and chief executive officer, Merck & Co., Inc. "We plan to work with the FDA to address what steps need to be taken before the application may be approved."
About ARCOXIA and Merck
The company submitted a revised NDA to the FDA on Dec. 30, 2003, to include efficacy data for ankylosing spondylitis and to provide additional cardiovascular safety data. In the NDA, Merck is seeking indications for ARCOXIA for the treatment of osteoarthritis, rheumatoid arthritis, chronic low back pain, acute pain, dysmenorrhea (menstrual pain), acute gouty arthritis and ankylosing spondylitis.
ARCOXIA has been launched in 48 countries worldwide in Europe, Latin America and the Asia-Pacific region. Merck will continue to work with regulatory agencies in the countries where ARCOXIA is approved, including the European Medicines Agency which recently announced plans for a safety review of the COX-2s, to assess whether changes to the prescribing information for this class of drugs, including ARCOXIA, are warranted.
Merck & Co., Inc. is a global research-driven pharmaceutical company. Merck discovers, develops, manufactures and markets a broad range of innovative products to improve human and animal health, directly and through its joint ventures.
Forward-Looking Statement
This press release contains "forward-looking statements" as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements involve risks and uncertainties, which may cause results to differ materially from those set forth in the statements. The forward-looking statements may include statements regarding product development, product potential or financial performance. No forward-looking statement can be guaranteed, and actual results may differ materially from those projected. Merck undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise. Forward-looking statements in this press release should be evaluated together with the many uncertainties that affect Merck's business, particularly those mentioned in the cautionary statements in Item 1 of Merck's Form 10-K for the year ended Dec. 31, 2003, and in its periodic reports on Form 10-Q and Form 8-K (if any) which the company incorporates by reference.
http://www.merck.com
"Approvable" FDA Scrisoarea pe nouã cerere de ARCOXIA (artritã ºi dureri) - "Approvable" FDA Letter on New Application for ARCOXIA™ (arthritis and pain) - articole medicale engleza - startsanatate