Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

Altana Omnaris nasal spray approval

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Altana's Omnaris (ciclesonide nasal spray) for the treatment of allergic rhinitis in adults and children 12 years of age and older clears FDA Oct. 23. Altana said it hopes to secure a marketing partner before introducing the new molecular entity; the firm's current goal is a 2007 launch. Omnaris is simultaneously "approvable" for use in children ages 2-11. An inhalation formulation of ciclesonide, developed with Sanofi-Aventis under the trade name Alvesco, has been approvable for asthma since 2004 (1Pharmaceutical Approvals Monthly January 2006, p. 13)...

You may also be interested in...



Altana Omnaris Adrenal Function Assessment Was "Not Ideal," FDA Says

Study design deficiences impeded Altana's attempt to distinguish Omnaris (ciclesonide) from other nasal corticosteroids as having less potential to suppress the cortisol system and adrenal function

Altana Omnaris Pediatric Program Had No Room For Error

Poorly executed pediatric trials impeded Altana’s attempt to gain approval of Omnaris (ciclesonide) nasal spray in children under 12 years old, FDA review documents indicate.

Oncology, CNS Agents May Dominate 2006 NME Approvals

Bristol-Myers Squibb’s multi-targeted kinase inhibitor dasatinib and Genta’s Bcl-2 inhibitor Genasense (oblimersen) could be approved for leukemia indications in the first half of 2006, if granted priority reviews. Both agents were submitted in late December.

Topics

UsernamePublicRestriction

Register

OM017175

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel