Basilea Pharmaceutica Ltd.: FDA Accepts For Review The Complete Response Submission To Ceftobiprole NDA

Main Category: Dermatology
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 01 Sep 2009 - 12:00 PDT

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Basilea Pharmaceutica Ltd. (SWISS: BSLN) announces that the U.S. Food and Drug Administration (FDA) has accepted the response submitted by the sponsor Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (PRD) as complete. The Complete Response submission addresses the FDA Complete Response Letter issued in November 2008 concerning the ceftobiprole NDA for complicated skin and skin structure infections.

The FDA informed Johnson & Johnson PRD that it considers the resubmission a complete, class 2 response. "We are pleased that the FDA has accepted for review the submission related to the Complete Response Letter. We look forward to the advancement of ceftobiprole through the FDA review process," commented Dr. Anthony Man, CEO.

Ceftobiprole is an anti-MRSA broad-spectrum cephalosporin antibiotic. It is marketed in Canada (ZEFTERA™) for the treatment of complicated skin and skin structure infections (cSSSI), including non-limb threatening diabetic foot infections without concomitant osteomyelitis and in Switzerland (Zevtera™) for the treatment of complicated skin and soft tissue infections (cSSTI) including diabetic foot infections without concomitant osteomyelitis.

Ceftobiprole is being developed through an exclusive worldwide collaboration between Basilea Pharmaceutica International Ltd. and Cilag GmbH International, a Johnson & Johnson company.

Source
Basilea Pharmaceutica Ltd.