| Add to balance / Manage account | User: | Log out |
| Prospect News home > News index > List of issuers A > Headlines for Altana AG > News item |
Altana submits New Drug Applications for Ciclesonide nasal spray in United States, Canada
By E. Janene Geiss
Philadelphia, March 7 - Altana Pharma US, Inc. said Tuesday that the Food and Drug Administration has accepted for filing the company's New Drug Application for Ciclesonide nasal spray.
A new drug submission for Ciclesonide nasal spray also was submitted to the Canadian authority Health Canada, according to a company news release.
Altana said it is seeking marketing approval for the treatment of nasal symptoms associated with seasonal and perennial allergic rhinitis.
Intranasal corticosteroids are considered to be the gold standard for the treatment of allergic rhinitis and they work by reducing inflammation, the major underlying cause of nasal symptoms, officials said.
The clinical development program for Ciclesonide nasal spray leading to submission in the United States and Canada was performed by Altana Pharma US, officials said.
Besides the nasal spray, Ciclesonide is the active substance of an inhaled corticosteroid that is already approved in 35 countries worldwide for the treatment of persistent asthma. A New Drug Application also has been filed with the FDA.
In addition, the Ciclesonide platform also will include a fixed combination product with a long-acting beta-agonist, currently in phase 2 clinical development.
Altana partners with Sanofi-Aventis in the United States and with Teijin in Japan on various Ciclesonide based products, officials said.
Altana Pharma US, based in Florham Park, N.J., is a wholly owned subsidiary of Altana Pharma AG, the pharmaceutical division of Altana AG, based in Konstanz, Germany. Altana Pharma focuses developing treatments of gastrointestinal and respiratory diseases.
© 2015 Prospect News.
All content on this website is protected by copyright law in the U.S. and elsewhere.
For the use of the person downloading only.
Redistribution and copying are prohibited by law without written permission in advance from Prospect News.
Redistribution or copying includes e-mailing, printing multiple copies or any other form of reproduction.