Cephalon receives second FDA Complete Response Letter for NUVIGIL sNDA Cephalon.

Meals and Drug Administration for the supplemental new drug program for NUVIGIL Tablets [C-IV] for the treating patients with extreme sleepiness associated with aircraft lag disorder caused by eastbound travel. Nevertheless, following several conversations with the company, and with all this second full response letter, the company believes that additional communications with the FDA will not bring about an approval of this application,’ stated Dr. Lesley Russell, Chief Medical Officer at Cephalon. ‘Because of this, the company is no more pursuing this indication.’.. Cephalon receives second FDA Complete Response Letter for NUVIGIL sNDA Cephalon, Inc. today announced that the company received a second Complete Response Letter from the U.S.For less serious injuries, make an effort to stabilize the damage as soon as it happens by firmly taking these quick steps: Remove clothing from around the injured component. Don’t force a limb out of the clothes, though. You may need to cut clothes off with scissors to prevent your child from having unnecessary added pain. A cold compress or ice pack wrapped in cloth Apply. Usually do not put ice directly on the skin. Place a makeshift splint on the injured part by: keeping the injured limb in the position you find it placing soft padding about the injured part placing something firm next to the injured portion, making sure it’s long enough to go past the joints above and beneath the injury keeping the splint in place with first-help tape or a wraparound bandage loosely Get medical care immediately, and don’t permit the child to eat, in the event surgery is needed.