Well back to the drawing board to gather up some additional data. We live in a world of data today, overloaded data for that matter, and decisions just are not as simple as they used to be. With all the additional side effects coming to light the FDA appears to be taking the same stance as everyone else, "give me more information". BD
Johnson & Johnson (NYSE: JNJ ) is the latest victim of the FDA’s tendency not to follow its panel's recommendation. Today the company announced that the FDA had rejected its current bid to expand the label of its antibiotic Doribax to include the treatment of hospital-acquired pneumonia. J&J will probably resubmit with more data in reply to the Complete Response letter. The drug is used to treat complicated internal infections and is already approved in Europe for that expanded use. Last month, an advisory panel said the drug was both safe and effective when tested for the expansion.
Well back to the drawing board to gather up some additional data. We live in a world of data today, overloaded data for that matter, and decisions just are not as simple as they used to be. With all the additional side effects coming to light the FDA appears to be taking the same stance as everyone else, "give me more information". BD
Johnson & Johnson (NYSE: JNJ ) is the latest victim of the FDA’s tendency not to follow its panel's recommendation. Today the company announced that the FDA had
rejected its current bid to expand the label of its antibiotic Doribax to include the treatment of hospital-acquired pneumonia. J&J will probably resubmit with more data in reply to the Complete Response letter. The drug is used to treat complicated internal infections and is already approved in Europe for that expanded use. Last month, an advisory panel said the drug was both safe and effective when tested for the expansion.
Johnson & Johnson Gets Rejected