May 7, 2008 – Trudell Medical International is pleased to announce the FDA approval of Alvesco(R) (ciclesonide) inhalation aerosol in combination with the AEROCOUNT(R) Dose Indicator. Alvesco, a novel inhaled corticosteroid, will be distributed in the U.S. by Sepracor Inc. under an agreement with Nycomed based in Europe.
The approval of Alvesco with the AEROCOUNT Dose Indicator marks a significant milestone for respiratory patients. AEROCOUNT Dose Counters and Indicators are designed to address the 2003 FDA guidance calling for the integration of dose counters for metered-dose inhalers (MDI) used to deliver medication to the lungs. The AEROCOUNT Dose Indicator customized for Alvesco numerically displays the number of doses left in a patient’s inhaler, and as they approach a low medication level, the indicator displays a warning in red. The use of color helps to send a strong visual reminder to patients to renew their prescription.
“We are very pleased to partner with Nycomed to integrate the AEROCOUNT Dose Indicator as part of the Alvesco MDI. The FDA approval is a validation of Trudell’s dose counting technology and our commitment to excellence in medical aerosol delivery devices and systems,” said Mark Pickard, Vice-President and General Manager of Trudell Medical International.
With the first patent dating back to January 1998, Trudell Medical International had an early start towards building an intellectual property base in dose counting consisting of 50 issued patents and patents pending. Leveraging over a decade of development and commercialization effort in dose counting solutions, Trudell Medical International is able to provide pharmaceutical partners with a turnkey solution.
(Source:www.pharmalive.com)
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