Notice: Function _load_textdomain_just_in_time was called incorrectly. Translation loading for the wordpress-seo domain was triggered too early. This is usually an indicator for some code in the plugin or theme running too early. Translations should be loaded at the init action or later. Please see Debugging in WordPress for more information. (This message was added in version 6.7.0.) in /var/www/html/wp-includes/functions.php on line 6260 J&JPRD Gets Complete Response Letter for Ceftobiprole | Contract Pharma

What are you searching for?

Sign in
Breaking News, Trials & Filings

J&JPRD Gets Complete Response Letter for Ceftobiprole

Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (J&JPRD) received a Complete Response letter from the FDA for ceftobiprole.

Author Image

By: Tim Wright

Editor-in-Chief, Contract Pharma

Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (J&JPRD) received a Complete Response letter from the FDA for ceftobiprole. The NDA was originally submitted in May 2007 for the treatment of complicated skin and skin structure infections (cSSSI), including diabetic foot infections.

The FDA has requested additional information and recommended additional studies be conducted in order to consider a future approval of ceftobiprole in this indication.

Ceftobiprole was licensed from Swiss-based Basilea Pharmaceutica Ltd. in February 2005. J&JPRD received an Approvable Letter for the ceftobiprole filing in March 2008, which J&JPRD responded to in August 2008. In November 2008, the company received a Complete Response letter recommending additional site audits. The company completed those audits and included the results in its June 2009 response to the FDA.

Add us as a preferred source on Google

Get the latest Contract Pharma news, insights and analysis in your Google Search and AI experiences.

Add Contract Pharma as a preferred source on Google (opens in a new tab)

Keep Up With Our Content. Subscribe To Contract Pharma Newsletters