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

.. 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. Meals and Drug Administration for the supplemental new drug application for NUVIGIL Tablets [C-IV] for the treatment of patients with extreme sleepiness associated with jet lag disorder resulting from eastbound travel. Nevertheless, following many conversations with the agency, and with all this second complete response letter, the business believes that additional communications with the FDA won’t result in an approval of the application, said Dr. Lesley Russell, Chief Medical Officer at Cephalon. As a result, the business is no pursuing this indication.Related StoriesAristada expanded discharge injection approved to take care of adults with schizophreniaVraylar capsules today accepted by FDA to take care of schizophrenia, bipolar disorder in adultsNovel study tool identifies hyperlink between unfavorable symptoms of schizophrenia and adverse scientific outcomesFor this study, experts used state-of-the-art equipment to link the increased loss of Dgcr8 to adjustments that impact a different mind framework, the auditory thalamus. For many years antipsychotic drugs have already been known to function by binding to a proteins called the D2 dopamine receptor .