As confirmed by the giant pharmaceutical company Pfizer on Wednesday, the US Food and Drug Administration has rejected the use of its medicine Lyrica as a sole treatment for generalized anxiety disorder, stressing that the data submitted in the application is insufficient to gain approval.
The decision, according to the drug manufacturer, came after Pfizer submitted its application once again, in response to a "not approvable" letter that was earlier issued by the regulator in August
2004.
"We are disappointed with the FDA's decision and will work with the agency to determine next steps", said Steve Romano, Vice President, Medical Affairs Head, Primary Care Business Unit.
Pfizer has further shared that the FDA is still in the process of reviewing a separate application for Lyrics to be used as adjunctive therapy for the treatment of general anxiety disorder or GDA.
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