Pharmaceutical Processing World

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

FDA Approves First Generic Risperidone to Treat Psychiatric Conditions

By Pharmaceutical Processing | July 7, 2008

The FDA has approved the first generic versions of Risperdal (risperidone) tablets. Risperdal is an antipsychotic drug used for the treatment of schizophrenia, bipolar disorder, and other psychiatric conditions. “This generic drug approval is another example of the FDA’s efforts to increase access to safe and effective generic drugs as soon as the law permits,” said Gary Buehler, director of the FDA’s Office of Generic Drugs in the Center for Drug Evaluation and Research. Varying strengths of risperidone tablets, manufactured by TEVA Pharmaceuticals USA, have been approved. Specific information about the strengths approved can be found at http://www.accessdata.fda.gov/scripts/cder/drugsatfda/. The labeling of the generic risperidone may differ from that of Risperdal because some uses of the drug are protected by patents and exclusivity. The generic risperidone products will have the same safety warnings as Risperdal, including a Boxed Warning that cautions that older patients with dementia-related psychosis treated with atypical anti-psychotic drugs are at increased risk of death compared with those taking placebo. Risperdal, and other antipsychotic medications, are not FDA-approved to treat dementia-related psychosis. The decision to use antipsychotic medications in the treatment of patients with symptoms of dementia is left to the discretion of the physician. Such use is often called “off-label” use and falls within the practice of medicine.

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
  • Advertise
  • SUBSCRIBE