Pfizer Inc.’s earlier-rejected, resubmitted application for the use of its Lyrica capsules CV as a mono-therapy for generalized anxiety disorder has met with yet another rejection by the US Food and Drug Administration (FDA).

The FDA, which had issued a Lyrica stand-alone treatment related “non-approvable” letter to Pfizer in August 2004, has concluded again that the data contained in the drugmaker’s New Drug Application for Lyrica is not sufficient enough to receive approval.

Nonetheless, despite the rejection of the application for the use of Lyrica as a mono-therapy, a separate Pfizer application for the drug’s use as adjunctive therapy for the treating general anxiety disorder is still under review by the FDA.

Evidently disappointed at the FDA’s rejection of the re-submitted Lyrica application, Steve Romano, Vice president, Medical Affairs Head, Primary Care Business Unit of Pfizer – the world’s leading drugmaker – said that the company intends to “work with the agency to determine next steps.”