Airomir hearing resolved with a VCU and other PMPRB updates

1- Airomir hearing resolved with a VCU:

The hearing on the drug product , Airomir, sold by 3M Canada Company, has been resolved with a Voluntary Compliance Undertaking (VCU). Airomir (salbutamol sulphate) was sold by 3M Canada prior to December 29, 2006 and is currently being sold by Graceway Canada Company. It is a CFC-Free 200 Metered dose Inhaler indicated for the treatment of asthma, chronic bronchitis and other breathing disorders. Airomir's price was within the PMPRB Guidelines until January 1, 2004, after which date the price exceeded the CPI adjusted MNE. The repayment of excess revenues amounted to $485.5K.

2- Upcoming hearing dates for the month of June:

Penlac Nail Lacquer (Sanofi-Aventis Canada) - Pre-hearing conference - June 6 Adderall XR (Shire BioChem Inc.) - hearing June 18 Quadracel & Pentacel (Sanofi Pasteur Limited) - Pre-hearing conference - June 25 Copaxone (Teva Neuroscience Canada) - June 27

3- HDAP September 10th meeting - deadlines to submit information:

June 10: Product Monograph Due (1 copy) July 10: Submission Due (7 copies)

4- Brogan Inc. would also like to also remind you of the upcoming July data filing:

It is now time to start planning for the July data filing. The deadline for the January- June 2007 data is July 30. Here is what is required for completing the filing:

International Pricing Data

International ex-factory list prices for the relevant countries are required, and these should be requested from your sources now. The International portion of the Form 2 submission (Block 5) can be prepared in advance of the domestic sales data, which will save time later when the deadline is looming. Don’t forget to include US DVA-FSS and Canadian list prices in the Block 5 data.

Transaction Data

The data required are the Canadian sales figures from January to June 2007. The number of units and net sales of each package size should be provided for the all patented products, by province and class of customer (Block 4).

If you would like assistance with the preparation and/or review of your data filing, do not hesitate to contact us.