Merck & Co., Inc. (MRK) Responds To FDA-Issued Approvable Letters For Arcoxia(R) (etoricoxib)
11/10/2006 10:59:42 AM
WHITEHOUSE STATION, N.J.--(BUSINESS WIRE)--Merck & Co., Inc. today announced that it has submitted a response to the “approvable” letters on the New Drug Applications (NDAs) for Arcoxia® (etoricoxib) issued by the U.S. Food and Drug Administration (FDA). According to current FDA policy for this type of submission, the review is targeted to be approximately six months (end of April 2007). The original NDA was submitted in December 2003 and a separate related NDA to add a 30 mg dose of ARCOXIA was submitted in April 2004. ARCOXIA has been under review by the FDA as an investigational selective COX-2 inhibitor since the original NDA was submitted in December 2003 and is currently available in 62 countries in Europe, Latin America, the Asia-Pacific region and Middle East/Northern Africa.