Mylan Inc arm gets US OK for Tolterodine tartrate tablets

By Admin
Share
Mylan Inc said its arm Mylan Pharmaceuticals Inc has secured final approval from the U.S. Food and Drug Administration for its abbreviated new drug app...

Mylan Inc said its arm Mylan Pharmaceuticals Inc has secured final approval from the U.S. Food and Drug Administration for its abbreviated new drug application for Tolterodine tartrate tablets of 1 mg and 2 mg respectively.

This product is the generic version of Pharmacia and Upjohn’s Detrol® Tablets.  It is indicated for treating overactive bladder with symptoms of urge urinary incontinence, urgency and frequency.

Tolterodine tartrate tablets had U.S. sales of approximately $61.5 million for 12 months ending September 30, 2012 as per IMS Health.

Thirty six of these pending ANDAs are potential first-to-file opportunities, representing $21.2 billion in annual brand sales for 12 months ending June 30, 2012.

Mylan is a global pharmaceutical company that offers portfolio of more than 1,100 generic pharmaceutical and several brand medications. It also offers a wide range of antiretroviral therapies, on which about one-third of HIV/AIDS patients in developing countries depend. It also operates one of the largest active pharmaceutical ingredient manufacturers and currently markets products in about 150 countries and territories.

The company has a workforce of over 18,000 people and is dedicated to improving the customer experience and increasing pharmaceutical access to consumers around the world.

It also operates a fully integrated specialty pharmaceuticals business, Mylan Specialty, which produces innovative medicinal therapies including EpiPen® auto-injector. 

Share

Featured Articles

NTT & Olympus: World's First Cloud Endoscopy System

NTT and medical technology company Olympus put on a demonstration, showing the IOWN APN's low-latency capability, for the first cloud endoscopy system

Richter BioLogics' New Biopharmaceutical GMP Facility

Richter BioLogics GmbH & Co KG's a new biopharmaceutical GMP facility in Germany will boost production capabilities and local employment

GE HealthCare's Pilot Study Shows Value of Portrait Mobile

A pilot study from GE Healthcare has shown the value of Portrait Mobile Continuous Monitoring Solution, a leap in post-surgical monitoring efficiency

50% of Teens to be Affected by Myopia Globally by 2050

Telehealth & COVID-19

NVIDIA’s AI Insights for Diabetes Prevention with GluFormer

Technology & AI

Novo Nordisk's CagriSema Next Gen Weight-Loss Treatment

Medical Devices & Pharma