Pharmaceutical Processing World

  • Home
  • Regulatory
    • Recalls
  • Pharmaceutical Processing
  • Facility
  • Supply Chain
  • Equipment and Materials
  • Contract Manufacturing
  • R&D 100 Awards

FDA Extends Nuvigil Jet Lag Review by 3 Months

By Pharmaceutical Processing | December 22, 2009

FRAZER, Pa. (AP) — The FDA needs more time to review Cephalon Inc.’s drug Nuvigil as a treatment for jet lag, Cephalon recently announced. Cephalon is seeking approval to market Nuvigil for the treatment of tiredness in jetlagged patients. The company said the FDA extended its review by three months, and a decision is now due by March 29, 2010. Cephalon said it had submitted new information about Nuvigil, and the agency decided it needed more time to review its application. The FDA’s decision had been expected by Dec. 29. Nuvigil, also called armodafinil, is on the market as a treatment for narcolepsy, excessive sleepiness caused by sleep apnea, and changes in work schedule. Cephalon is hoping to apply for approval in other indications over the next five years.

Related Articles Read More >

FDA logo
FDA prevented 317 drug shortages in 2021
Pfizer-BioNTech vaccine vial
Pfizer, BioNTech moving forward on seeking COVID-19 vaccine EUA for youngest children
FDA logo
FDA curtails use of Janssen COVID-19 vaccine over blood clotting concerns
FDA logo
FDA sends warning letters to CBD and delta-8 THC product vendors

DeviceTalks Tuesdays

DeviceTalks Tuesdays

MEDTECH 100 INDEX

Medtech 100 logo
Market Summary > Current Price
The MedTech 100 is a financial index calculated using the BIG100 companies covered in Medical Design and Outsourcing.

Need Pharmaceutical Processing news in a minute?

We Deliver!
Pharmaceutical Processing Enewsletters get you caught up on all the mission critical news you need. Sign up today.
Enews Signup
Pharmaceutical Processing World
  • Subscribe to Our Free E-Newsletter
  • Contact Us
  • About Us
  • Advertise With Us
  • R&D World
  • Drug Delivery Business News
  • Drug Discovery & Development
  • DeviceTalks
  • MassDevice
  • Medical Design & Outsourcing
  • MEDICAL TUBING + EXTRUSION
  • Medical Design Sourcing
  • Medtech100 Index

Copyright © 2022 WTWH Media LLC. All Rights Reserved. The material on this site may not be reproduced, distributed, transmitted, cached or otherwise used, except with the prior written permission of WTWH Media
Privacy Policy | Advertising | About Us

Search Pharmaceutical Processing World

  • Home
  • Regulatory
    • Recalls
  • Pharmaceutical Processing
  • Facility
  • Supply Chain
  • Equipment and Materials
  • Contract Manufacturing
  • R&D 100 Awards