for Immediate Release
Contact: Claire R. Wynters, Public Relations & Media
(Mumbai, January 10, 2012)
Pharmaceutical and biotechnology major Wockhardt has received final approval from the United States Food & Drug Administration (US FDA) for marketing 50 mcg nasal spray of Fluticasone which is used in treatment of allergic rhinitis. Fluticasone nasal spray is the generic name for the brand Flonase®, marketed in the United States by Glaxo Smithkline. Wockhardt is launching the product immediately.
According to IMS Health, the total market for this product in the US is about $580 million and there are only three other generic versions of the product in the United States. Fluticasone nasal spray is amongst the most widely used corticosteroids in treating allergic rhinitis.
“Wockhardt is amongst the few companies to have an approval for Fluticasone nasal spray,” said Wockhardt Chairman Dr. Habil Khorakiwala. “We have always endeavoured to develop and market products based on challenging technologies and this approval of a nasal spray is another step in that direction. The product involved development of complex precisely controlled formulation as well as the device for the spray. The regulatory approval also required us to conduct clinical trials”
In the US generic pharmaceutical market, Wockhardt has been consistently growing market shares for all its products. In many instances, Wockhardt, by virtue of being amongst the few players to market technically challenging products has reaped the advantage of being an early entrant. Wockhardt will be manufacturing the nasal spray at its facility in Morton Grove, Illinois, USA. The technology for this nasal spray was developed in-house.
Criterium, Inc. is a full-service, global CRO (contract research organization) that offers a unique mix of high-quality clinical research services and communication processes for the biopharmaceutical, pharmaceutical, and medical device industries to manage trials from initial planning to approval. Founded in 1991, Criterium’s services are customized to fit each client’s specific needs, providing a seamless flow of data and information from the investigative site through Criterium and back to the sponsor — 24/7, in real-time.
Criterium’s experienced team manages and implements clinical trials using technology-based solutions. Dedicated clinical professionals are committed to providing personal service and to forming strong and productive relationships with clients. Criterium’s well-established staff are trained according to ICH GCP guidelines.
Corporate headquarters are located in Saratoga Springs, New York
with offices in Florida, California, South Africa, India, and Canada,
and representatives in-country in The Netherlands, Israel, and Russia.
This multi-national approach enables Criterium to provide time- and
cost-efficient study management and monitoring to all our clients.
Wockhardt is a high technology global pharmaceuticals and biotechnology major with innovative multi-disciplinary research and development programs. It has 4 research centers and world-class manufacturing plants globally. Wockhardt has a multi-ethnic workforce of 6500 people from 14 different nationalities. Flonase® is a registered trademark of Glaxo Smithkline.