FDA Provides Response to Eisai New Drug Application
FDA has issued a Refusal to File letter in response to the company's New Drug Application for perampanel.
Eisai Inc., a research-based human health care company, announced last week that the FDA has issued a Refusal to File letter in response to the company's New Drug Application (NDA) for perampanel (E2007), an investigational drug, for the treatment of partial-onset seizures associated with epilepsy which was submitted in May 2011.
Perampanel is a highly selective non-competitive AMPA-type glutamate receptor antagonist, discovered and being developed by Eisai.
Upon preliminary review, the FDA requested reformatting and reanalyses of some datasets in the dossier to assist with a substantive review. Eisai believes that no new non-clinical or clinical studies are required to support this filing. This letter does not comment on the approvability of the d
Related News
-
News Introducing the Pharmaceutical Sustainability Ecosystem from CPHI
The Sustainability Collective from CPHI unveils the groundbreaking Pharmaceutical Sustainability Ecosystem to drive pharmaceutical knowledge sharing, connection, and collaboration in order to change the face of sustainability in pharmceutical... -
News US Government shutdown leads to the FDA grinding to a halt
The US Congress reached a deadlock after not being able to come to an agreement regarding funding, specifically reaching an impasse when Republicans and Democrats were unable to reach an agreement regarding Obamacare subsidies. The resulting shutdown o... -
News Biosimilars for the better: an expert view from Ecolab
Ecolab expert Renato Azevedo shares his insights on the current state of the biosimilars market in pharmaceuticals, after a high number of biosimilar drug approvals throughout the year confirming the shift of focus in this field. -
News US FDA announces new priority vouchers for accelerated review times
The US FDA announced a new priority program for drug developers – the Commissioner’s National Priority Voucher (CNPV) program aims to enhance the health interests of the US by allowing drug developers to redeem a voucher, shortening th... -
News CPHI Podcast Series: US drug policy – exploring the executive orders
The latest episode of the CPHI Podcast Series provides a timely overview of the recent policy changes in the USA, with President Trump signing excecutive orders to change drug pricing under a 'Most Favoured Nation' scheme.
-
News PhRMA trade association issues comments on Section 232 investigation
The Pharmaceutical Research and Manufacturers of America (PhRMA), an American trade association representing groups in the pharmaceutical industry, issued a letter on May 6, 2026 to the Department of Commerce regarding the Section 232 National Security... -
News Pharmaceutical Packaging Market Prospects: Shifting regional policies
The pharmaceutical packaging industry is experiencing significant transformation in 2025, driven by regulatory changes, supply chain challenges, and sustainability initiatives. The US BIOSECURE Act, passed through the House of Representatives in Septem... -
News The next 15 drugs up for negotiation with Medicare include several blockbusters
By now, everyone is quite familiar with the drug price negotiations taking place between drug companies and the Centres for Medicare & Medicaid Services (CMS) in the USA as part of measures being taken to reduce the cost of drugs for patients, to make ...