Pfizer Lipitor OTC Bid Would Face FDA Evolving On Switch Innovation

Pfizer looks to lessons from prior statin attempts and an environment open to new ways to inform consumer decisions as it considers filing for a Lipitor switch, which will depend on the outcome of a large actual use trial.

FDA’s interest in fostering innovation in OTC switches may be the most significant factor working in favor of Lipitor as Pfizer Inc. maneuvers toward a possible attempt to bring the statin to nonprescription status.

Research recommendations and regulatory changes in recent years also contribute to an environment likely to be more open to a statin

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