Navigation Links
Zydus Pharmaceuticals (USA) Inc. Announces FDA Final Approval for the Generic Version of Topamax(R) Tablets
Date:3/27/2009

PRINCETON, N.J., March 27 /PRNewswire/ -- Zydus Pharmaceuticals announced today that it has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Topiramate Tablets USP, 25mg, 50mg, 100mg, and 200mg. This product is available for immediate shipment.

Topiramate tablets are indicated as an initial monotherapy in patients 10 years old or older with partial onset or primary generalized tonic-clonic seizures. It is also indicated as an adjunctive therapy for adults and pediatric patients ages 2 - 16 with partial onset seizures, or primary generalized tonic-clonic seizures, and in patients 2 years of age or older with seizures associated with Lennox-Gastaut syndrome. Topiramate tablets are the generic version of Ortho-McNeil-Janssen's Topamax(R) Tablets and according to Wolters Kluwer Health (formerly NDC Health) that product had sales over $3.2 billion for the 12 months ending February 28, 2009.

Zydus Pharmaceuticals (USA) Inc., located in Princeton, N.J., is the U.S. division of Cadila Healthcare. Cadila Healthcare is India's 4th largest pharmaceutical company and has a presence in over 50 countries worldwide. This is Zydus Pharmaceutical's 42nd tentative or final approval over the last four years. For more information on Zydus Pharmaceuticals please visit our website at www.zydususa.com.


'/>"/>
SOURCE Zydus Pharmaceuticals (USA) Inc.
Copyright©2009 PR Newswire.
All rights reserved

Page: 1

Related medicine news :

1. Arena Pharmaceuticals to Present at the NewsMakers in the Biotech Industry Conference
2. Schering-Plough/Merck Pharmaceuticals Announce FDA Filing Acceptance of New Drug Application for Loratadine/Montelukast Tablet
3. Provectus Pharmaceuticals, Inc. Begins Phase 2 Clinical Trial for Metastatic Melanoma
4. Idenix Pharmaceuticals to Present at Two Upcoming Investor Conferences
5. Vista Partners Updates Coverage on Tapestry Pharmaceuticals
6. Transcept Pharmaceuticals, Inc. to Present at UBS 2007 Global Life Sciences Conference
7. Crystal Research Associates, LLC Issues Executive Informational Overview(R) (EIO(R)) on Tapestry Pharmaceuticals, Inc.
8. Amylin Pharmaceuticals to Webcast Corporate Overview During 43rd Annual Meeting of the European Association for the Study of Diabetes
9. Major Pharma Clinical Case Studies From Amgen, AstraZeneca, GSK, Intermune, Cephalon Inc, Sunesis Pharmaceuticals and Dartmouth Medical School During Fall Clinical Focused Programs
10. Provectus Pharmaceuticals, Inc. releases summary results of phase 1 metastatic melanoma study
11. Class Settlement Could Result in Considerable Savings for Certain Consumers of Prescription Pharmaceuticals
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:4/30/2016)... ... 30, 2016 , ... “Aging well is a challenge for all of us, but there are things we can ... Kohli . “Research is showing more and more that there are simple, yet important steps ... as we age.” Top priorities Dr. Kohli’s recommends for her patients include;, , ...
(Date:4/29/2016)... (PRWEB) , ... April 29, 2016 , ... In an ... mother and divorcee, shares her enthusiasm for Botox and lip injections, which she underwent ... famous youth oriented Coachella Valley Music and Arts Festival. The article explains that Ms. ...
(Date:4/29/2016)... ... April 29, 2016 , ... Our bodies are bombarded daily ... confront and deal with these stressors is to adopt a more healthful diet, but ... you. Risa Groux, a certified Holistic Nutritionist and the creator of the Newport Beach ...
(Date:4/29/2016)... ... April 29, 2016 , ... The ... in repaying their loans, more information about their loan terms and accounts, and ... student loan debt, including federal and private loans, has reached $1.3 trillion, with ...
(Date:4/29/2016)... ... April 29, 2016 , ... Spine Team Texas, a comprehensive spine ... announce one of their physicians has been invited to be a featured speaker at ... Practice Review conference on April 30, 2016. , Dr. R. Scott McPherson, a ...
Breaking Medicine News(10 mins):
(Date:4/27/2016)... 27, 2016 Global  urinalysis ... billion by 2022, according to a new report ... (Logo: http://photos.prnewswire.com/prnh/20150105/723757 ) , ... efficiency and accuracy delivered by the new generation ... novel urinalysis instruments and consumables. For instance, the ...
(Date:4/27/2016)... -- At the Sachs CEO forum in ... 2 clinical study of its lead drug candidate, STR001, ... (CI) surgery. This large, placebo-controlled, double-blind, phase 2 study ... and France . STR001 is ... of surgery. "Despite advances in cochlear implant technology, a ...
(Date:4/26/2016)... , April 26, 2016 Hill-Rom Holdings, Inc. ... a management presentation at the Deutsche Bank 41 st ... 2:50 p.m. EDT. You are invited to listen ... http://ir.hill-rom.com/events.cfm or access it directly at http://edge.media-server.com/m/p/mr4uxgas . ... hour after conclusion of the live event and accessible at ...
Breaking Medicine Technology: