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Schering-Plough's About-Face On OTC Claritin

Just ten months after telling the FDA that granting Claritin OTC status posed a "major health risk," Schering-Plough--threatened by the genericization of its blockbuster drug and possible OTC competitors on the horizon--has changed its tune and asked the agency to approve the switch. Its a move which may presage a sea change in drug marketing as pressure could mount for other NSAs, as well as medications in other therapeutic categories, to go non-prescription.

At an FDA advisory committee meeting last May, Schering-Plough Corp. 's CMO and SVP, medical affairs, Robert Spiegel, MD testified that changing Claritin (loratadine) from prescription to OTC status would pose a "major health risk." He went on to say that the drug company "strongly believe[d] that loratadine should be a prescription medication."

What a difference ten months make. In March 2002, Schering announced that it had made a "strategic business and medical...

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