XML Feed for RxPG News   Add RxPG News Headlines to My Yahoo!   Javascript Syndication for RxPG News

Research Health World General
 
  Home
 
 Latest Research
 Cancer
 Psychiatry
 Genetics
 Surgery
 Aging
 Ophthalmology
 Gynaecology
 Neurosciences
 Pharmacology
  Anti-Inflammatory
  Antivirals
  Antihypertensives
  Anticholesterol
  Anti-Clotting Drugs
  Anti Cancer Drugs
  Hypnotics
   Ramelteon
  PPI
  Antibiotics
  Analgesics
  Surfactants
  Fatty Acids
  Adrenergics
  Metals
  Varenicline
 Cardiology
 Obstetrics
 Infectious Diseases
 Respiratory Medicine
 Pathology
 Endocrinology
 Immunology
 Nephrology
 Gastroenterology
 Biotechnology
 Radiology
 Dermatology
 Microbiology
 Haematology
 Dental
 ENT
 Environment
 Embryology
 Orthopedics
 Metabolism
 Anaethesia
 Paediatrics
 Public Health
 Urology
 Musculoskeletal
 Clinical Trials
 Physiology
 Biochemistry
 Cytology
 Traumatology
 Rheumatology
 
 Medical News
 Health
 Opinion
 Healthcare
 Professionals
 Launch
 Awards & Prizes
 
 Careers
 Medical
 Nursing
 Dental
 
 Special Topics
 Euthanasia
 Ethics
 Evolution
 Odd Medical News
 Feature
 
 World News
 Tsunami
 Epidemics
 Climate
 Business
Search

Last Updated: Aug 19th, 2006 - 22:18:38

Hypnotics Channel
subscribe to Hypnotics newsletter

Latest Research : Pharmacology : Hypnotics

   DISCUSS   |   EMAIL   |   PRINT
Approval for Clonazepam Orally Disintegrating Tablets
Aug 11, 2005, 22:58, Reviewed by: Dr.

Klonopin (Clonazepam) is useful alone or as an adjunct in the treatment of the Lennox-Gastaut syndrome (petit mal variant), akinetic and myoclonic seizures, and, for the treatment of panic disorder, with or without agoraphobia, as defined in DSM-IV.

 
Barr Pharmaceuticals, Inc. today announced that its subsidiary, Barr Laboratories, Inc., has received final approval from the U.S. Food and Drug Administration (FDA) for its application to manufacture and market Clonazepam Orally Disintegrating Tablets, 0.125 mg, 0.25 mg, 0.5 mg, 1 mg & 2 mg, the generic equivalent of Hoffman La Roche's Klonopin(R) Wafers. The Company plans to launch its product immediately.

Klonopin (Clonazepam) is useful alone or as an adjunct in the treatment of the Lennox-Gastaut syndrome (petit mal variant), akinetic and myoclonic seizures, and, for the treatment of panic disorder, with or without agoraphobia, as defined in DSM-IV.
 

- United States Food and Drug Administration
 

www.barrlabs.com

 
Subscribe to Hypnotics Newsletter
E-mail Address:

 

Klonopin Wafers had total annual sales of approximately $18 million, based on IMS sales data for the twelve months ended June 2005.

Barr Pharmaceuticals, Inc. is a holding company whose principal subsidiaries, Barr Laboratories, Inc. and Duramed Pharmaceuticals, Inc., develop, manufacture and market generic and proprietary pharmaceuticals.

Forward-Looking Statements

Except for the historical information contained herein, the statements made in this press release constitute forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Forward-looking statements can be identified by their use of words such as "expects," "plans," "projects," "will," "may," "anticipates," "believes," "should," "intends," "estimates" and other words of similar meaning. Because such statements inherently involve risks and uncertainties that cannot be predicted or quantified, actual results may differ materially from those expressed or implied by such forward-looking statements depending upon a number of factors affecting the Company's business. These factors include, among others: the difficulty in predicting the timing and outcome of legal proceedings, including patent-related matters such as patent challenge settlements and patent infringement cases; the outcome of litigation arising from challenging the validity or non- infringement of patents covering our products; the difficulty of predicting the timing of FDA approvals; court and FDA decisions on exclusivity periods; the ability of competitors to extend exclusivity periods for their products; our ability to complete product development activities in the timeframes and for the costs we expect; market and customer acceptance and demand for our pharmaceutical products; our dependence on revenues from significant customers; reimbursement policies of third party payors; our dependence on revenues from significant products; the use of estimates in the preparation of our financial statements; the impact of competitive products and pricing on products, including the launch of authorized generics; the ability to launch new products in the timeframes we expect; the availability of raw materials; the availability of any product we purchase and sell as a distributor; the regulatory environment; our exposure to product liability and other lawsuits and contingencies; the increasing cost of insurance and the availability of product liability insurance coverage; our timely and successful completion of strategic initiatives, including integrating companies and products we acquire and implementing our new enterprise resource planning system; fluctuations in operating results, including the effects on such results from spending for research and development, sales and marketing activities and patent challenge activities; the inherent uncertainty associated with financial projections; changes in generally accepted accounting principles; and other risks detailed from time-to-time in our filings with the Securities and Exchange Commission, including in our Annual Report on Form 10-K for the fiscal year ended June 30, 2004.

The forward-looking statements contained in this press release speak only as of the date the statement was made. The Company undertakes no obligation (nor does it intend) to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except to the extent required under applicable law.

CONTACT: Carol A. Cox of Barr Pharmaceuticals, Inc., +1-201-930-3720,

Web site: http://www.barrlabs.com/


Related Hypnotics News

Ramelteon shows less potential to foster abuse and dependence
Ramelteon showed significant reduction in time to fall asleep
CX717 Reverses Effects of Sleep Deprivation on Brain
Approval for Clonazepam Orally Disintegrating Tablets
NDA accepted to review Indiplon for the treatment of insomnia
FDA Approves Ramelteon, the First 'No Abuse' Drug for Insomnia
FDA approved Ramelteon
Older adults falling asleep faster with Ramelteon


For any corrections of factual information, to contact the editors or to send any medical news or health news press releases, use feedback form

Top of Page

 

© Copyright 2004 onwards by RxPG Medical Solutions Private Limited
Contact Us