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Claritin: Drugs
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WebMD Sweepstakes: Win a $3,000 Spa Getaway or a Weekly Prize Worth $250 - Play Now During 1998 and 1999, Claritin was the drug that was most advertised directly to consumers in the US. It was used by 3% of women of childbearing age. Since late in 2002, Claritin has been available in the US without a prescription.
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If Schering switches Claritin to over-the-counter status on its own, it could prevent prescription generic versions from hitting the market and eroding Clarinex sales. If the government decides certain additional studies are needed to ensure that the drug is safe, an additional period of exclusivity would be added. Then, Schering might not have to deal with over-the-counter generic competition for another three years, says Michael Krensavage, an analyst at Raymond James & Associates. The FDA will consider the move to sell Claritin over the counter on Nov. 28.
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The company is suffering from a massive decline in sales in its allergy franchise since Claritin lost patent protection in 2002. Its hepatitis-C franchise has ... seen big declines since Roche launched a competitor and the market for these drugs shrunk as a whole. One of the drugs in the hepatitis-C group, Rebetol, faces generic competition imminently, so the company has been trying to get rid of extra inventory.
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FDA has approved Claritin (loratadine) as an over-the-counter (OTC) allergy drug product. Previously available only as a prescription drug, Claritin is approved for seasonal allergic rhinitis -- a condition that causes runny nose, nasal congestion, sneezing, and itchy nose, throat, eyes, and ears.
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Dr. Berger said that Claritin did not work for all patients. Some of those patients may now turn to the older, sedating drugs available over the counter, he said, rather than paying higher copayments on Allegra, Zyrtec and Clarinex.
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