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Over-the-counter status sought by maker of Claritin. (Clinical Rounds: Availability by end of 2002).

Schering-Plough Corp. has asked the Food and Drug Administration for permission to market all formulations of Claritin over the counter by year's end.

The company's patent on Claritin (loratadine) expires in December, and Johnson & Johnson and Wyeth have both filed petitions with the FDA to market generic versions of the antihistamine.

Claritin, along with other second-generation antihistamines Allegra (fexofenadine) and Zyrtec (cetirizine), was the subject of a precedent-setting petition for a switch to over-the-counter (OTC) status filed with the FDA by WellPoint Health Networks Inc., the parent company of Blue Cross of California.

Despite strong opposition from manufacturers, physicians, and professional associations, the FDA's Nonprescription Drugs Advisory Committee recommended an OTC switch for the antihistamines at the May 2001 meeting.

At the hearing, Schering-Plough's senior vice president and chief medical officer, Dr. Robert Spiegel, claimed that actual-use trials would need to be conducted, that new labeling would need to be developed, and that a thorough risk assessment would need to be performed before Claritin could switch to OTC.

"The safety profiles of the second-generation antihistamines in an OTC setting are not fully known," he said.

Schering-Plough declined to comment on whether or not more safety data have since been collected or on the content of its submission to the FDA. Claritin's status change will be considered at an FDA meeting this month. At that time, the agency will also consider whether loratadine's labeling can carry an indication for treatment of chronic idiopathic urticaria in an OTC setting.

Clarinex (desloratadine), Claritin's prescription-only successor, was approved in January and is indicated for the treatment of chronic idiopathic urticaria and allergic rhinitis.

According to Robert Seidman, Pharm.D., chief pharmacy officer at WellPoint, "Claritin is a [preferred] drug, and there's really nothing in the clinical literature that differentiates it from any of the prescription antihistamines, whether it's Clarinex, Allegra, or Zyrtec."

"For those patients who have treatment failures or who are intolerant to Claritin, then the other agents will be made available," said Dr. Seidman. However, reimbursement for Allegra and Zyrtec may get tougher. WellPoint plans to place the antihistamines in the third tier of its formulary, or require special authorization for use.

There were no indications from the makers of Allegra or Zyrtec that they plan to change their prescription-only status any time soon.

A spokesperson for Aventis Pharmaceuticals, maker of Allegra, said that "[Allegra is] a prescription antihistamine, and we plan to continue to compete effectively in that market." Pfizer, which did not offer any comments to the FDA panel on WellPoint's petition last May, did not return phone calls seeking comment.
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Title Annotation:Schering-Plough Corp.
Author:Franklin, Deeanna
Publication:Internal Medicine News
Article Type:Brief Article
Geographic Code:1USA
Date:Apr 1, 2002
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