Pfizer Withdraws Application for Extension of Macugen Indication
Pfizer stated its decision to withdraw was based on the CHMP’s view that the data provided so far does not allow the Committee to conclude on a positive benefit-risk balance in the applied for indication.
Pfizer Limited has formally notified the European Medicines Agency about the company's decision to withdraw its application for an extension of the therapeutic indication for Macugen (pegaptanib sodium), 0.3 mg solution for injection.
In its official letter, the company stated that its decision to withdraw the application was based on the CHMP’s view that the data provided so far does not allow the Committee to conclude on a positive benefit-risk balance in the applied for indication. Macugen continues to be authorised in the currently approved indication.
On 14 June 2010, Pfizer Limited submitted an application to extend the marketing authorisation for Macugen to include the
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