BioCentury
ARTICLE | Clinical News

Zeftera ceftobiprole regulatory update

September 7, 2009 7:00 AM UTC

Basilea said FDA accepted a response from partner Johnson & Johnson to a November complete response letter for an NDA for ceftobiprole to treat complicated skin and skin structure infections (cSSSIs). The agency designated the response a Class 2 resubmission, giving the application a 6-month review. The PDUFA date is undisclosed. In the letter, FDA said further resolution of "deficiencies of study conduct" was necessary and that there was a "failure to ensure proper monitoring" of studies of the compound (see BioCentury, Dec. 8, 2008).

Last month, FDA issued a warning letter to J&J in which the agency concluded the company had not adhered to applicable requirements and regulations related to the conduct of clinical trials of ceftobiprole to treat cSSSIs (see BioCentury, Aug. 24). The company said it is finalizing its response to the warning letter. J&J also said that it had submitted its response to the complete response letter prior to receiving the warning letter. In April, Basilea filed a request for arbitration to the Netherlands Arbitration Institute alleging that J&J mishandled its clinical and regulatory responsibilities for the product in the EU and the U.S under the partners' 2005 deal (see BioCentury, March 2). ...