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FDA issues Warning Letter to Johnson & Johnson (JNJ)

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FDA issues Warning Letter to Johnson & Johnson JNJ

Basilea Pharmaceutica Ltd. announces that the company was notified today that the FDA issued to Johnson & Johnson Pharmaceutical
Research and Development, L.L.C. (NYSE: JNJ) a Warning Letter related to
clinical trials for ceftobiprole for the treatment of complicated
skin and skin structure infections.

The Warning Letter to Johnson&Johnson PRD relates to observations
from FDA sponsor and clinical site inspections conducted during the
first part of 2008.

Consistent with Basilea's earlier press releases, the Warning Letter
asserts that there was a failure to ensure proper monitoring of the
studies as well as deficiencies in study conduct.

The FDA has posted the Warning Letter at www.fda.gov.

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

 

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