Cephalon receives FDA Complete Response Letter for NUVIGIL supplemental fresh drug application Cephalon, Inc. today announced the company has received a Total Response letter from the U male condition .S. Related StoriesTARSA Therapeutics' TBRIA NDA approved by FDA for reviewMylan announces U.S. Launch of generic AXERT tabletsAlnylam presents positive ongoing stage 2 open-label expansion data for Patisiran and RevusiranAs the initial company to review a treatment substitute for improve wakefulness associated with jet lag disorder, Cephalon worked carefully with the FDA to create a special protocol evaluation that could evaluate the connection with an average eastbound airline traveler.0001] and the PGI-S> Although we reached statistical significance on both main endpoints, the entire Response letter raised queries regarding the robustness of the PGI-S data, said Dr.
We are looking towards offering individuals in Brazil better access to high-quality, effective and more affordable treatment options that can also help alleviate some of Brazil's rising health care costs, continued Teixeira. Remsima and Inflectra were approved by the European Medicines Agency in 2013 and are currently available in most Europe. Celltrion submitted an application to ANVISA to approve Remsima and Hospira will marketplace the product exclusively in Brazil.. Celltrion receives authorization for infliximab biosimilar antibody from Brazil’s ANVISA Hospira, Inc. The medication will become marketed by Hospira. Hospira also marketplaces and offers biosimilar infliximab in 26 Europe and in Canada under the brand name Inflectra.