FDA holds OTC allergy drugs switch meeting

The FDA said it would discuss an overthe-counter (OTC) switch of Aventis' Allegra (fexofenadine HCI), Schering's Claritin (loratadine), and Pfizer's Zyrtec (cetrizine HCI) at a joint meeting of its Nonprescription Drugs and PulmonaryAllergy Drugs Advisory Committee meeting in May. This move by FDA

is unprecedented because the OTC switch was not manufacturer-requested, but rather was sought by California Blue Cross in a citizen petition citing a regulation that allows FDA to exempt prescription requirements for NDAs that the agency determines are unnecessary for the protection of public health. A switch would permit health plans to remove the drugs from their prescription drug formularies, and thus avoid reimbursing for them.