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news.Complete Response addresses FDA's Complete Response Letter concerning ceftobiprole for complicated skin and skin structure infections
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Basilea Pharmaceutica ( Basilea) has reported that the FDA has accepted the complete response submitted by the Johnson & Johnson.
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.
Ceftobiprole is being developed through an exclusive worldwide collaboration between Basilea and Cilag, a Johnson & Johnson company.
Anthony Man, CEO at Basilea, said: The FDA informed Johnson & Johnson 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.