Pharmaceutical Processing World

  • Home
  • Regulatory
    • Recalls
  • Pharmaceutical Processing
  • Facility
  • Supply Chain
  • Equipment and Materials
  • Contract Manufacturing
  • Resources
    • Voices
  • Advertise
  • SUBSCRIBE

Lupin Receives FDA Approval for Generic Nuvigil Tablets

By Lupin Limited | November 30, 2016

Lupin Pharmaceuticals, Inc. has received final approval from the FDA to market a generic version of Cephalon, Inc.’s Nuvigil tablets.

Lupin Limited announced that its U.S. subsidiary Lupin Pharmaceuticals, Inc. (LPI) has received final approval for its Armodafinil tablets 50 mg, 150 mg, 200 mg and 250 mg from the United States Food and Drug Administration (FDA) to market a generic version of Cephalon, Inc.’s Nuvigil tablets 50 mg, 150 mg, 200 mg and 250 mg. LPI shall commence promoting the product in the U.S. shortly.

Lupin’s Armodafinil tablets 50 mg, 150 mg, 200 mg and 250 mg are the AB rated generic equivalents of Cephalon, Inc.’s Nuvigil tablets 50 mg, 150 mg, 200 mg and 250 mg. Armodafinil tablets are indicated to improve wakefulness in adult patients with excessive sleepiness associated with obstructive sleep apnea (OSA), narcolepsy or shift work disorder (SWD).

Nuvigil tablets had U.S. sales of $515.6 million (IMS MAT September 2016).

Lupin is a transnational pharmaceutical company developing and delivering a wide range of branded and generic formulations, biotechnology products and APIs globally. The company is a significant player in the cardiovascular, diabetology, asthma, pediatric, CNS, GI, anti-infective and NSAID space and holds a global position in the anti-TB segment.

(Source: Business Wire)

Related Articles Read More >

Doctor, woman patient and tablet for consulting with results, medical info and talk for healthcare with mockup space. Japanese medic, digital touchscreen or show video for surgery, wellness or advice.
Putting patients first in clinical trials
Confidently navigate the transition from bench to batch
Merck
FDA approves Merck’s Winrevair to treat pulmonary arterial hypertension
kobayashi pharmaceutical logo
Report: Japan health authorities investigate Kobayashi Pharmaceutical factory after five deaths
“ppw
EXPAND YOUR KNOWLEDGE AND STAY CONNECTED
Get the latest news, technologies, and developments in Pharmaceutical Processing.

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.
Pharmaceutical Processing World
  • Subscribe to our E-Newsletter
  • Contact Us
  • About Us
  • R&D World
  • Drug Delivery Business News
  • Drug Discovery & Development
  • DeviceTalks
  • MassDevice
  • Medical Design & Outsourcing
  • MEDICAL TUBING + EXTRUSION
  • Medical Design Sourcing
  • Medtech100 Index
  • R&D 100 Awards

Copyright © 2025 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
  • Resources
    • Voices
  • Advertise
  • SUBSCRIBE