FDA DECLINES TO REVIEW CARDIOME'S CARDIOVASCULAR DRUG NDA
The U.S. FDA has declined to review Canada-based Cardiome Pharma's new drug application (NDA) for an investigational cardiovascular drug, the company announced.
In a recent press release, Cardiome said its development partner, Astellas Pharma, has received a "refusal to file" letter from the FDA for RSDD1235 (iv), designed for acute conversion of atrial fibrillation. The company said the FDA's reasons included "inconsistencies and omissions in the databases submitted with the NDA" but added that this action is not an indication of the potential approvability of the drug in the future
Cardiome CEO Bob Reider said in a statement that the company is reviewing the NDA with the intent to resolve the FDA's concerns.
The FDA's decision not only delays the marketing of the drug but also puts off a $10 million milestone payment, under the agreement with Astellas, due to Cardiome on acceptance of the NDA. As of Dec. 31, 2005, the company reported having approximately $8.4 million cash on hand.