According to Trading Markets, Pfizer Inc said today that it has submitted paediatric data for Lipitor (atorvastatin) to the European Medicines Agency (EMEA), after the EMEA concluded that Pfizer's programme studying the use of Lipitor in children with high cholesterol complied with its criteria. This submission includes a new chewable form of Lipitor, including a paediatric-appropriate 5 mg dose (see also Welt Online, RTT News ).Just over a week ago, Dr Reddy's filed an application to manufacture a generic version of the drug (see here and here).
2 comments:
A bit misleading to combine the two stories if I may say so. Dr Reddy is applying in the US where the patent is about to expire in 2010. In Europe it's protected by SPCs lasting till november 2011.
To anonymous: quite right -- for the sake of clarity I should have added the words "in the United States" at the conclusion of the final sentence.
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