- Launch has been tracking in line with other blockbuster Central Nervous System drug launches.
- Over 900,000 prescriptions since launch.
- Over 50% (23,000) of high volume physicians prescribing.
- Coupons are now less than 15% of total prescriptions.
- ADDERALL XR(R) - ADHD - Sales for 2007 were up 19% to $1,030.9 million (2006: $863.6 million).
- DAYTRANA(TM) - ADHD.
- Sales for 2007 were up 156% to $64.2 million (2006: $25.1 million).
- On January 9, 2008 the FDA issued a Warning Letter to Noven Pharmaceuticals Inc. ("Noven") which related to Noven's manufacture of DAYTRANA. Further regulatory action could result if the FDA's concerns are not satisfied fully. Noven submitted a response to the FDA on January 30, 2008.
- LIALDA(TM)/MEZAVANT(R) - Ulcerative Colitis.
- LIALDA, the only once-daily oral formulation of mesalamine was approved by the FDA in January 2007 and launched in the US in March 2007, acquiring 8.0% share of the US oral mesalamine market at December 31, 2007. Sales for 2007 were $50.5 million.
- Shire's share of the US oral mesalamine market from LIALDA and PENTASA(R) combined was 26.0% at February 8, 2008.
- The product was launched in the UK in November 2007 as MEZAVANT XL, with further launches planned in the EU in 2008. It was launched in Canada on January 28, 2008 as MEZAVANT.
- FOSRENOL(R) - Hyperphosphatemia - International launches continued and FOSRENOL is now available in 24 countries with worldwide sales in 2007 of $102.2 million (2006: $44.8 million).
- DYNEPO(R) - Anemia associated with chronic kidney disease ("CKD") - DYNEPO is the first and only erythropoiesis-stimulating agent produced in a human cell line. The product has been launched in several EU countries and sales for 2007 were $14.2 million.
- ELAPRASE(R) - Hunter syndrome.
- On February 11, 2008 ELAPRASE was approved for commercial sale by the
|SOURCE Shire plc|
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