Teva Receives FDA Approval For Oral Contraceptive

Anonymous User | Login

Published: 01-Jul-2009

Tri-Lo Sprintec is a generic version of Ortho McNeil Janssen's oral contraceptive, Ortho Tri-Cyclen Lo

Pharmaceutical firm Teva has received FDA approval for the Abbreviated New Drug Application (ANDA) to market Tri-Lo Sprintec, a generic version of Ortho McNeil Janssen's oral contraceptive, Ortho Tri-Cyclen Lo.

Teva has been awarded a 180-day period of marketing, as it has filed the first ANDA containing a paragraph IV certification for this product.

Teva is currently involved in patent litigation concerning this product in the US District Court for the District of New Jersey. A trial date has not been set yet.

Teva develops, manufactures and markets generic and human pharmaceuticals, as well as active pharmaceutical ingredients. The company also manufactures animal health pharmaceutical products.

Wyeth, Catalyst Sign Agreement To Develop, Commercialize Factor VIIa Products

Wyeth to support the discovery, research and preclinical development ...

Teva Completes Enrollment In Second Oral Laquinimod Phase-III Trial

Clinical trial designed to evaluate efficacy, safety and tolerability of laquinimod versus placebo ...

Trubion Extends Research Period With Wyeth

Wyeth to pay $3.3 million in exchange for committed research services ...

Abbott Initiates Spirit Prime Trial

Results to be used to support regulatory filing for Xience Prime ...

MorphoSys Extends Alliance With Schering-Plough

Schering-Plough to have continued access to HuCAL GOLD ...

ImClone, Bristol-Myers Squibb Sign Agreement With Merck

For co-development and co-commercialization of Erbitux in Japan ...

Bristol-Myers Squibb Reports Consistent Safety, Effectiveness For Rheumatoid Arthritis Trial

Orencia, a selective co-stimulation modulator of T-cell activation. ...

Merck’ Declaration In Response To FDA's Update On Singulair

Singulair, supported by data from controlled clinical trials in more than 20,000 patients ...

Wyeth Provides Phase-III Updates For Pneumococcal Drug

Prevenar13, immunogenic for all serotypes and showed safety profile similar to Prevenar ...

Merck Terminates Research Collaboration, License Agreement

Entered the collaboration with Neuromed in March, 2006 ...

Network Sites

Contract Research Clinical Trials Contract Services Drug Delivery Drug Discovery & Development OTC Regulatory Affairs Process and Production IT and Software Laboratory Instrumentation Manufacturing Fine & Specialty Chemicals Medical Devices Business Review Inward Investment Packaging

Mail sent successfully

Tell your friend about this article

Please enter a valid email address

Please enter your name

Please enter the mail body

Your Name: *

Your Email: *

Friend's Email: *

Email Body: *: I thought you would be interested in this article : http://www.pharmaceutical-business-review.com/news/teva_receives_fda_approval_for_oral_contraceptive_090701/

Suppliers To This Sector

Browse A-Z

# A B C D E F G H I J K L M N O P Q R S T U V W X Y Z

World Courier

Offering Fully-Integrated GxP-Compliant Global Transport and Storage for the Pharmaceutical Industry...

WebWise Learning

Turning Information into Working Knowledge ...

Vetter Pharma International

High-Quality Aseptically Pre-Filled Injection Systems, Cartridges and Vials ...

Valsynthese

Hazardous Chemistry in Safe Hands ...

USB

Products from Affymetrix ...

Umicore Precious Metals Chemistry

Chemicals and Catalysts for Industrial Applications ...

White Papers

Browse A-Z

# A B C D E F G H I J K L M N O P Q R S T U V W X Y Z

Related Companies

Schering-Plough Corporation

Schering-Plough Corporation (Schering-Plough) is a pharmaceutical company focused on di ...

Teva Pharmaceutical Industries Limited

Teva Pharmaceutical Industries Limited (Teva), a global pharmaceutical company, is enga ...

Merck & Co., Inc.

Merck & Co., Inc. (Merck) is a global research-driven pharmaceutical company engaged in ...

Abbott Laboratories

Abbott Laboratories (Abbott) is a global health care company. It is principally engaged ...

Wyeth

Wyeth is engaged in developing and providing pharmaceuticals and healthcare products fo ...

Suppliers Product News

World Courier CTSCS Depots Provide Dedicated Storage for GMO Products

In response to growing client demand and based on recently-established international biosafety regulations, World Courier has begun rolling out dedicated storage areas for GMO-derived pharmaceutical products throughout its global investigational drug storage network.

World Courier Triples Clinical Trial Storage Capacity Worldwide with Two New Facilities and Client-Driven Expansion

World Courier expands its GMP-compliant Clinical Trial Supply Chain Services (CTSCS) network, facilitating access to growing pharmaceutical markets in Africa and Australia.

World Courier Achieves Coveted GxP-Compliant Status Worldwide with Focus on GDP, Quality Management

With a fully GxP-compliant transport and supply chain system in place, World Courier meets the most demanding industry requirements for managing time- and temperature-sensitive clinical trial materials used in global studies.

Vetter Dedicates New Facility in Suburban Chicago

The new facility will enable collaboration very early in development process

Pharma Supplier Vetter Shares Pride in Consistent Growth and International Success with Distinguished Visitor Minister zu Guttenberg

Economics and Technology Minister visits global leader's headquarters in southern Germany.

Vetter Packages Success with New Facility

Vetter's new secondary packaging operation allows the company to double its production in half the time.

Free Newsletter Sign-up

Sign up, and we will send you a free Pharmaceutical report on “ Combination Products – Evolution of the Medical Equipment Industry” from GlobalData worth $750