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FDA requests further data on J&JPRD's ceftobiprole
28 Nov 2008
Regulatory Affairs
Johnson & Johnson Pharmaceutical Research and Development (J&JPRD) has said the US Food and Drug Administration (FDA) stated that it can not currently approve ceftobiprole.
According to J&JPRD, the FDA has requested that the firm conducts additional audit work of clinical investigator sites and addresses specific questions regarding site monitoring.
The new drug application relates to the use of ceftobiprole as a treatment for complicated skin and skin structure infections, including diabetic foot infections.
J&JRD has confirmed that it will now work with its co-development partner Basilea Pharmaceutica as part of its efforts to resolve the issues that have been raised by the FDA.
Ceftobiprole was approved earlier this year in Canada and more recently gained approval in Switzerland.
Meanwhile, Johnson & Johnson has just revealed it has commenced a cash tender offer to purchase all outstanding shares of common stock in Omrix Pharmaceuticals.
