Ceftobiprole roadblock by FDA now 16 months since NDA and still counting, for a life saving MRSA antibiotic.
Also delayed more than one year for JNJ is Ionsys, approved for in hospital postoperative pain (transdermal fentanyl iontophoresis) in Europe. The main side effect is of course respiratory depression (especially in patients with chronic lung disease and patients with sleep apnea).
Give JNJ credit for shifting to MNT cosmetics (implants, fillers and neurotoxin). Sign of the times. These are products that will not be paid for by government or insurance, but out of the consumers' pocket. Sold for 90% premium, but still 20% below Jan 1 SP.
This acquisition leaves only 13.8 billion cash for JNJ to consider RD, the neuropathology spectrum............. So JNJ lets get on with it.
Choice of RD, Sleep apnea, AD and ADHD in Europe with no FDA roadblock.